Quantitative FIT tests in the Czech Republic Past, present...

Quantitative FIT tests in the Czech RepublicPast, present and future

Quantitative FIT tests in the Czech RepublicQuantitative FIT tests in the Czech RepublicPast, present and futurePast, present and future

European Colorectal Cancer Days - Brno, 26. April 2014European Colorectal Cancer European Colorectal Cancer DaysDays -- BrnoBrno,, 26. April 26. April 20120144

Kocna PetrKocna PetrKocna Petr

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Laboratory of Gastroenterology of theInstitute of Medical Biochemistry and Laboratory Diagnostics

shows long-standing – 40 years experiences with FOBT analytics

Laboratory of Gastroenterology of theLaboratory of Gastroenterology of theInstitute of Medical Biochemistry and Laboratory DiagnosticsInstitute of Medical Biochemistry and Laboratory Diagnostics

shows longshows long--standing standing –– 40 years experiences with FOBT analytics40 years experiences with FOBT analytics

1970 – 1980 different chemically based tests with guaiac or o-tolidine were compared for reproducibility, sensitivity and assuranceHaemoccult, HemDetect, KryptoHaem SSW

1970 1970 –– 19801980 different chemically based tests different chemically based tests with guaiac or owith guaiac or o--tolidine were compared for tolidine were compared for reproducibility, sensitivity and assurancereproducibility, sensitivity and assuranceHaemoccult, HemDetect, KryptoHaem SSWHaemoccult, HemDetect, KryptoHaem SSW

1st GENERATION OF FOBTGUAIAC TEST: g-FOBT

1st GENERA1st GENERATTION OF FOBTION OF FOBTGUAGUAIAIAC TEST: gC TEST: g--FOBTFOBT

An adapted program of colorectal cancer screening.Fric P, Zavoral M, Dvoráková H et al. - Hepatogastroenterology. 1994

An adapted program of colorectal cancer screening.An adapted program of colorectal cancer screening.Fric P, Zavoral M, Dvoráková H et al. Fric P, Zavoral M, Dvoráková H et al. -- Hepatogastroenterology. 1994Hepatogastroenterology. 1994

Haemoccult exclusively has been recommended for CRC screening with highest reproducibility

Haemoccult exclusively has been recommended Haemoccult exclusively has been recommended for CRC screening with highest reproducibilityfor CRC screening with highest reproducibility

40 years ago40 years ago40 years ago

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g-FOBT – GUAJAC TEST, HAEMOCCULTgg--FOBT FOBT –– GUAJAGUAJACC TEST, HAEMOCCULTTEST, HAEMOCCULT

gg--FOBT FOBT WITH SENSITIVITYWITH SENSITIVITY LESSLESS 30% 30% FINISHED AT END OF 2012FINISHED AT END OF 2012

44

1990 – 2000 different immunochemically tests were compared for reproducibility, sensitivity and assurance, compared with Haemoccult,and validated by colonoscopy.ImmoCare, HemeSelect, Hemolex, Actim FB, Hexagon OBTI

1990 1990 –– 20002000 different immunochemically tests different immunochemically tests were compared for reproducibility, were compared for reproducibility, sensitivitysensitivity and and assurance, compared with Haemoccult,assurance, compared with Haemoccult,and validated by colonoscopy.and validated by colonoscopy.ImmoCare, HemeSelect, Hemolex, Actim FB, ImmoCare, HemeSelect, Hemolex, Actim FB, Hexagon OBTIHexagon OBTI

None of iFOBT test has been recommended for CRCA screening.iFOBT tests are very different in sensitivity, very high false positivity -

more then 25%, and variable sample preparation

None of iFOBT testNone of iFOBT test has been recommendedhas been recommended for CRCA screening.for CRCA screening.iFOBT tests are very different in sensitivity, very high false piFOBT tests are very different in sensitivity, very high false positivity ositivity --

more then 25%, and variable sample preparationmore then 25%, and variable sample preparation

Ferkl M, Kocna P, Fric P. - Cas Lek Cesk. 1992Benesova A, Fric P, Zavoral M, Kocna P, et al. - Cas Lek Cesk. 1993

Dvorak M., Kocna P. Vanickova Z. - Cas Lek Cesk. 2002 Dvorak M., Kocna P. et al. - Z.- Facharzt. 2003

Ferkl M, Kocna P, Fric P. Ferkl M, Kocna P, Fric P. -- Cas Lek Cesk. 1992Cas Lek Cesk. 1992Benesova A, Fric P, Zavoral M, Kocna P, et al. Benesova A, Fric P, Zavoral M, Kocna P, et al. -- Cas Lek Cesk. 1993Cas Lek Cesk. 1993

Dvorak M., Kocna P. Vanickova Z. Dvorak M., Kocna P. Vanickova Z. -- Cas Lek Cesk. 2002 Cas Lek Cesk. 2002 Dvorak M., Kocna P. et al. Dvorak M., Kocna P. et al. -- Z.Z.-- Facharzt. 2003Facharzt. 2003

i-FOBT QUALITATIVE, RAPID TESTsii--FOBT FOBT QUQUALITATIVALITATIVEE, RAPID TEST, RAPID TESTss


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FOBT - THE PAST20 YEARS WE USED g-FOBT WITH LOW SENSITIVITYBUT THE SAME RELIABILITY IN ALL REGIONS OF THE CZECH REPUBLIC

FOBT FOBT -- THE PASTTHE PAST20 YEARS WE USED g20 YEARS WE USED g--FOBT FOBT WITH WITH LOW SENSITIVITYLOW SENSITIVITYBUT THE BUT THE SAME RELIABILITYSAME RELIABILITY IN ALL IN ALL REGIONS OF THE CZECH REPUBLICREGIONS OF THE CZECH REPUBLIC

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i-FOBT methods for screening in the Czech Republic in 2013ii--FOBT FOBT methods formethods for screening screening in the Czech Rin the Czech Republicepublic in 2013in 2013

Report of Committee for colorectal cancer screening Ministry of Health Care, Czech Republic, Meeting - March 25, 2014

Report of Committee for colorectal cancer screening Report of Committee for colorectal cancer screening Ministry of Health Care, Czech Republic, Ministry of Health Care, Czech Republic, MMeeting eeting -- March 25, 2014March 25, 2014

g-FOBT 5%gg--FOBT FOBT 55%%Laboratory FIT 9%Laboratory FIT 9%Laboratory FIT 9%

POCT FIT 11%POCT FIT 11%POCT FIT 11%

Qualitative FIT 65% - 13 diferent methodsQualitative FIT 65% Qualitative FIT 65% -- 13 diferent methods13 diferent methods

SURVEY IN GENERAL PRACTITIONERS IN 2014SURVEY IN GENERAL PRACTITIONERS IN 2014SURVEY IN GENERAL PRACTITIONERS IN 2014

2nd GENERATION OF FOBTQUALITATIVE FIT: i-FOBT

2nd GENERA2nd GENERATTION OF FOBTION OF FOBTQUALITATIVE FIT: iQUALITATIVE FIT: i--FOBTFOBT

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77HIGH RANGE of iFOBT RAPID TESTS

AVAILABLE NOW IN THE CZECH REPUBLICHIGH RANGE ofHIGH RANGE of iFOBT RAPID TESTiFOBT RAPID TESTSS

AVAILABLE NOW AVAILABLE NOW ININ THE CZECH REPUBLICTHE CZECH REPUBLIC


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ii--FOBT FOBT SENSITIVITY COULD BE SENSITIVITY COULD BE 22x x HIGHER ASHIGHER AS HAEMOCCULTHAEMOCCULT

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iFOBT Rapid tests available in the CR from 20 producersiFOBT tests varied highly in the sensitivity and accuracyiFOBT tests sensitivity varied from 100 ng Hb/ml to 2000 ng Hb/mlRapid iFOBT tests use very different sampling devicesRapid iFOBT tests varied in the Hb/extract buffer stability

iFOBT Rapid testiFOBT Rapid testss available in the Cavailable in the CR R from from 2020 producersproducersiFOBT testiFOBT testss varied highly in the varied highly in the sensenssitivititivity and accuracyy and accuracyiFOBT testiFOBT tests sensitivity varieds sensitivity varied from from 100 ng Hb/ml 100 ng Hb/ml tto 2o 2000000 nng Hb/mlg Hb/mlRapid iFOBT testRapid iFOBT testss use very use very different sampling devicesdifferent sampling devicesRapid iFOBT testRapid iFOBT testss varied in the varied in the Hb/extraHb/extract buffer stabilityct buffer stability

Haug U, Hundt S, Brenner H. - Am J Gastroenterol. 2010 Mar;105(3):682-690 Quantitative immunochemical fecal occult blood testing for colorectal adenoma detection:

evaluation in the target population of screening and comparison with qualitative tests.

Haug U, Hundt S, Brenner H. Haug U, Hundt S, Brenner H. -- Am J Gastroenterol. 2010 Mar;105(3):682Am J Gastroenterol. 2010 Mar;105(3):682--690 690 Quantitative immunochemical fecal occult blood testing for colorQuantitative immunochemical fecal occult blood testing for colorectal adenoma detection: ectal adenoma detection:

evaluation in the target population of screening and comparison evaluation in the target population of screening and comparison with qualitative tests.with qualitative tests.

Mayo Clinic study of 750 subjects, colonoscpy verifiedFIT qualitative - false positivity - 7.4% FIT quantitative - false positivity - 3.8%

Mayo Clinic studMayo Clinic studyy of of 750 750 subjectssubjects, , ccolonosolonosccpy py verifiedverifiedFIT FIT ququalitativalitativee -- falfalsese popossitivititivity y -- 7.4% 7.4% FIT FIT quantitativequantitative -- falfalsese popossitivititivity y -- 3.8% 3.8%

Colorectal Cancer Screening Committee, DDW 2012 WorkshopExpert Working Group – Fit for Screening - prof. Stephen Halloran

Director: NHS Bowel Cancer Screening

Colorectal Cancer Screening Committee, DDW 2012 WorkshopColorectal Cancer Screening Committee, DDW 2012 WorkshopExpert Working Group Expert Working Group –– Fit for Screening Fit for Screening -- prof. prof. StephenStephen HalloranHalloran

DirectorDirector: NHS: NHS BowelBowel Cancer ScreeningCancer Screening

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FIT testFIT test SamplingSampling Conc.Conc. RatioRatio cutcut--offoff cutcut--offoff

mg/mlmg/ml

11

9,29,2

1010

1010

99--1818

22

22--6,66,6

100100--200200

22--44

ng/mlng/ml mmg/gg/g

ColonViewColonView 1mg1mg//2ml2ml 0.500.50 4040 8080

immoimmo--CareCare--CC 11.5 mg/2.11.5 mg/2.5ml5ml 4.604.60 5050 1111

FOB TestFOB Test 10mg10mg//2ml2ml 5.005.00 4040 88

OCOC--LightLight 10mg10mg//2ml2ml 5.005.00 5050 1010

EpiTuubEpiTuub®® iFOBiFOB 55--10mg10mg/1./1.1ml1ml 4,54,5--99 5050 5.55.5--1111

HemaHema--screen™screen™ x /1.7x /1.7--1.1.8ml8ml 1.001.00 5050 5050

FOB testFOB test 33--10mg10mg//3ml3ml 1.01.0--3,33,3 1010 3.33.3--1010

HbHb FECALEFECALE 100100--200mg200mg//2ml2ml 5050--100100 4040 0.40.4--0.80.8

Actim Fecal BloodActim Fecal Blood 1010--20mg20mg//10ml10ml 1.01.0--2.02.0 5050 2525--5050

EasyEasy--CardCard 200200

SureScreenSureScreen FOBFOB 5050

1010

UNITS & CUT-OFF VALUE (ng Hb/ml / mg Hb/g stool)UNITS & UNITS & CUTCUT--OFF OFF VALUEVALUE ((ng Hb/ml ng Hb/ml // mmg Hb/g stog Hb/g stoolol))

Tests with Tests with identicalidentical cutcut--off in Hb ng/mloff in Hb ng/mlmay have up to may have up to 200x times higher, or lower200x times higher, or lower, cut, cut--off in off in mmg Hb/g stoolg Hb/g stool

1111

FOBT - THE PAST20 YEARS WE USED g-FOBT WITH LOW SENSITIVITY BUT THE SAME RELIABILITY IN ALL REGIONS OF THE CZECH REPUBLIC

FOBT FOBT -- THE PASTTHE PAST20 YEARS WE USED g20 YEARS WE USED g--FOBT FOBT WITH LOW SENSITIVITY WITH LOW SENSITIVITY BUT THE SAME RELIABILITY IN ALL BUT THE SAME RELIABILITY IN ALL REGIONS OF THE CZECH REPUBLICREGIONS OF THE CZECH REPUBLIC

FOBT - THE PRESENTIN 2013 WE CHANGED TO i-FOBT (FIT) WITH 2-TIMES HIGHER SENSITIVITYBUT DISTINCTLY INCREASING VARIABILITYIN REGIONS OF THE CZECH REPUBLIC

FOBT FOBT -- THE PRESENTTHE PRESENTIN 2013 WE CHANGED TO iIN 2013 WE CHANGED TO i--FOBT (FIT) FOBT (FIT) WITH WITH 22--TIMES HIGHER SENSITIVITYTIMES HIGHER SENSITIVITYBUT BUT DISTINCTLY INCREASING VARIABILITYDISTINCTLY INCREASING VARIABILITYIN REGIONS OF THE CZECH REPUBLICIN REGIONS OF THE CZECH REPUBLIC

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QUANTITATIVE Hb ANALYSIS IN STOOLQUANTITATIVE Hb ANALYSIS IN STOOLQUANTITATIVE Hb ANALYSIS IN STOOL

Qualitative, rapid tests, quantified by the scanner/software

POCT analysers at general practitioners

Chemical/biochemical analysers at hospital/laboratories

Qualitative, rapid tests, quantified by the scanner/softwareQualitative, rapid tests, quantified by the scanner/software

POCTPOCT analysers at general practitionersanalysers at general practitioners

Chemical/biochemical analysers at hospital/laboratoriesChemical/biochemical analysers at hospital/laboratories

3rd GENERATION OF FOBTQUANTITATIVE FIT: qi-FOBT3rd GENERA3rd GENERATTION OF FOBTION OF FOBT

QUANTITATIVE FIT: qiQUANTITATIVE FIT: qi--FOBTFOBTStarted 5 years agoStarted 5 years agoStarted 5 years ago

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qi-FOBT/FIT - QUANTITATIVE Hb ANALYSIS IN STOOLqqii--FOBTFOBT/FIT /FIT -- QUANTITATIVE Hb ANALYSIS IN STOOLQUANTITATIVE Hb ANALYSIS IN STOOL

qqii--FOBT FOBT SENSITIVITY COULD BE SENSITIVITY COULD BE 33x x HIGHER ASHIGHER AS HAEMOCCULTHAEMOCCULT

RAPID iFOBT QUALITATIVE TESTRAPIDRAPID iFOBTiFOBT QUQUALITATIVALITATIVEE TESTTEST

STANDARD PC - SCANNERSTANDARD PC STANDARD PC -- SCANNERSCANNER

PC - NOTEBOOKPC PC -- NOTEBOOKNOTEBOOK

EVALUATION OF EVALUATION OF COLOCOLOUURED BAND INTENSITYRED BAND INTENSITYCOMPARING WITH DIGITAL / COLOUR STANDARDCOMPARING WITH DIGITAL / COLOUR STANDARD

QUANTIFICATION OF iFOBT TEST = ONLY PC'S VISUALISATIONQUANTIFICATION OF iFOBT TEST = ONLY PC'S VISUALISATION1414

1515

qi-FOBT / FIT POCT & LABORATORY ANALYSERSqqii--FOBT FOBT / FIT POCT & LABORATORY ANALYSERS/ FIT POCT & LABORATORY ANALYSERS

SmartPlus EurolyserSmartPlus EurolySmartPlus Eurolysserer

i-Chroma Boditechii--Chroma BoditechChroma Boditech

QuikRead OrionQuikReadQuikRead OrionOrion

SENTi-FIT 270 SentinelSENTiSENTi--FITFIT 270270 SentinelSentinel

OC-DIANA EikenOCOC--DIANADIANA EikenEikenOC-Sensor EikenOCOC--SensorSensor EikenEiken

QuikReadGo OrionQuikReadGo OrionQuikReadGo Orion

SENTi-FIT mini SentinelSENTiSENTi--FITFIT minimini SentinelSentinel

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QUANTITATIVE FIT ANALYSERS IN CZECH REPUPLICQUANTITATIVE FIT ANALYSERS IN CZECHQUANTITATIVE FIT ANALYSERS IN CZECH REPUPLICREPUPLIC

Map of the Czech Republic with marked locationsMap of the Czech Republic with marked locationswhere the quantitative analysis of Hb in stool, where the quantitative analysis of Hb in stool,

controlled with the SEKK external control quality, is availablecontrolled with the SEKK external control quality, is available

50 100 150 200 250 300 350100

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Dmax=40%

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EXTERNAL CONTROL QUALITY SYSTEM in CREXTERNAL CONTROL QUALITY SYSTEM in CREXTERNAL CONTROL QUALITY SYSTEM in CR

Eiken OCEiken OC--SensorSensor

Sentinel FOBGold Sentinel FOBGold

Eurolyser Eurolyser -- FOB FOB

OrionOrion QuikReadQuikRead

CV CV -- 8.78.711 %%

CV CV -- 1177..006 %6 %

CV CV -- 68.15 %68.15 %

CV CV -- 32.32.6060 %%

SEKK EHK FOB 2011/2013

VARIABILITY of FITs

SEKK SEKK EHK EHK FOB FOB 2011/2012011/20133

VARIABILITVARIABILITY ofY of FITFITss

Kocna P., Zima T., Budina M., Ichiyanagi T.: External Quality Assessment (EQA) for Quantitative Fecal Blood in Stool (FIT). Biochimica Clinica, 2013, 37, 423

Kocna P., Zima T., Budina M., Ichiyanagi T.: External Quality AsKocna P., Zima T., Budina M., Ichiyanagi T.: External Quality Assessment (EQA) sessment (EQA) for Quantitative Fecal Blood in Stool (FIT). Biochimica Clinica,for Quantitative Fecal Blood in Stool (FIT). Biochimica Clinica, 2013, 372013, 37, , 423423

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Automated analysers for qiFOBT are ready to start CRC screeningwith qiFOBT optimised for Czech Republic screening

EQAS control system is since January 2012 available

Automated analysers for qiFOBT are ready to start CRC screeningAutomated analysers for qiFOBT are ready to start CRC screeningwith qiFOBT optimised for Czech Republic screeningwith qiFOBT optimised for Czech Republic screeningEQAS control system is since January 2012 availableEQAS control system is since January 2012 available

National screening programme in the Czech Republicshould be modified to use quantitative qiFOBT technology

National screening programme in the Czech RepublicNational screening programme in the Czech Republicshould be modifiedshould be modified to use to use quantitative qiFOBTquantitative qiFOBT technologytechnology

Committee for CRC screeningMinistry of Health

of the Czech Republic

Committee forCommittee for CRCCRC screeningscreeningMinistry of HealthMinistry of Health

of the Czech Republicof the Czech Republic

Quantitative immunochemical qi-FOBT OC-SensorMeeting with EC & EP – Prague, January 11, 2012

Quantitative immunochemical qiQuantitative immunochemical qi--FOBT OCFOBT OC--SensorSensorMeeting with EC & EP Meeting with EC & EP –– Prague, January 11, 2012Prague, January 11, 2012


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QUANTITATIVE Hb STOOL ANALYSIS IN PRAGUEQUANTITATIVE Hb STOOL ANALYSIS IN PRAGUEQUANTITATIVE Hb STOOL ANALYSIS IN PRAGUE

Kocna P., Májek O., Blaha M.: Clinical and epidemiological importance of analyzing laboratory data with the data source I-COP.

Sborník Medsoft 2014 - March 25; 110-122 on-line: http://creativeconnections.cz/medsoft/2014.html

Kocna P.,Kocna P., MájekMájek O.,O., BlahaBlaha M.: Clinical and epidemiological importance M.: Clinical and epidemiological importance of analyzing laboratory data with the data source Iof analyzing laboratory data with the data source I--COP.COP.

Sborník MedsoftSborník Medsoft 2014 2014 -- March 25; 110March 25; 110--122 122 onon--line: http://line: http://creativeconnectionscreativeconnections..czcz//medsoftmedsoft/2014.html/2014.html

Quantitative determination of Hb in stool Eiken OC-Sensor micro analyserGeneral Faculty Hospital Prague

15 000 analysis in 5 years (2008 - 2013)The analytical data-mining tool I-COP

(Cancer Care Information Centre) compareLaboratory data - FIT - Hb in stool

with National Cancer Registry output

Quantitative determination of Hb in stool Quantitative determination of Hb in stool Eiken Eiken OCOC--Sensor miSensor miccroro analyseranalyserGeneral Faculty Hospital PragueGeneral Faculty Hospital Prague

15 000 analysis15 000 analysis in 5 years (2008 in 5 years (2008 -- 2013)2013)The analytical dataThe analytical data--mining tool Imining tool I--COPCOP

(Cancer Care Information Centre) compare(Cancer Care Information Centre) compareLaboratory dataLaboratory data -- FIT FIT -- Hb in stoolHb in stool

with with National Cancer RegistryNational Cancer Registry outputoutput

EXPERIENCES IN GENERAL FACULTY HOSPITAL - PRAGUE, 2008 - 2013EXPERIENCES IN GENERAL FACULTY HOSPITAL EXPERIENCES IN GENERAL FACULTY HOSPITAL -- PRAGUE, 2008 PRAGUE, 2008 -- 20132013

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DETECTED COLORECTAL CANCERSDETECTED COLORECTAL CANCERSDETECTED COLORECTAL CANCERS

ng/mlng/ml nn FIT +FIT +

7575 292292 7.057.05 %%

> 1000> 1000 4747 1.131.13 %%


7575 11287287 19.6219.62 %%

> 1000> 1000 331111 4.744.74 %%

AGE 50 – 90 YEAR ( n = 4145 )AGE 5AGE 50 0 –– 990 0 YEARYEAR ( n = 4145 )( n = 4145 ) AGE 50 – 90 YEAR ( n = 6561 )AGE AGE 50 50 –– 90 90 YEARYEAR ( n = ( n = 66561 561 ))

Patients of the Center for Preventive Care & GPs

Patients of the Center for Patients of the Center for Preventive Care & GPsPreventive Care & GPs

Patients specialized hospital clinics outpatient and inpatients

Patients specialized hospital clinics Patients specialized hospital clinics outpatient and inpatientsoutpatient and inpatients

Detected CRC – 11/64DetectedDetected CRCCRC –– 1111/64/64 Detected CRC – 53/64DetectedDetected CRCCRC –– 5353/64/64

CRC detection rate CRC detection rate -- 2.652.65/1000 FIT/1000 FITAverage time FIT Average time FIT -- surgery: surgery: 5.345.34 monthsmonths

CRC detection rate CRC detection rate -- 8.088.08/1000 FIT/1000 FITAverage time FIT Average time FIT -- surgery: surgery: 2.952.95 monthsmonths

2121

C180 - C181C180 C180 -- C18C1811 C187 - C200C187C187 -- C200C200

CRC TUMOR - BOWEL LOCALISATIONCRCCRC TUMOR TUMOR -- BOWELBOWEL LOCALISATIONLOCALISATION

C182 - C183C182C182 -- C183C183 C184 - C186C184C184 -- C186C186

25%2525%%

12.5%112.2.5%5%17.2%117.27.2%%

45.3%4545.3.3%%

2222

C180 - C18125%

C180 C180 -- C18C181125%25%

C187 - C20045.3%

C187C187 -- C200C20045.3%45.3%

30%30%30%

15%15%15%10%10%10%

45%45%45%

Johns Hopkins Colon Cancer Centerhttp://www.hopkinscoloncancercenter.org

Johns Hopkins ColonJohns Hopkins Colon Cancer CenterCancer Centerhttp://www.http://www.hopkinscoloncancercenterhopkinscoloncancercenter..orgorg

The frequency of tumors in different localisations corresponding published papers

The frequency of tumors in different localisations The frequency of tumors in different localisations corresponding published paperscorresponding published papers

C182 - C18317.2%

C182C182 -- C183C18317.2%17.2%

C184 - C18612.5%

C184C184 -- C186C18612.5%12.5%

CRC TUMOR - BOWEL LOCALISATIONCRCCRC TUMOR TUMOR -- BOWELBOWEL LOCALISATIONLOCALISATION

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810 ng/ml(180-1646)810 810 ng/mlng/ml(180(180--1646)1646)

969 ng/ml(346-1855)969 969 ng/mlng/ml(346(346--1855)1855)

CRC TUMOR - BOWEL LOCALISATION & FIT VALUECRCCRC TUMOR TUMOR -- BOWELBOWEL LOCALISATIONLOCALISATION & FIT VALUE& FIT VALUE

Hb ng/ml values are not significantly different

according to tumor localisation

Hb ng/ml values Hb ng/ml values are not significantly different are not significantly different

according to tumor localisationaccording to tumor localisation

The OC-Sensor FIT could be used reliably for CRC screening in any tumor localisationThe OCThe OC--Sensor FIT could be used reliably Sensor FIT could be used reliably

for CRC screening in any tumor localisationfor CRC screening in any tumor localisation

627 ng/ml(309-1422)627 627 ng/mlng/ml(309(309--1422)1422)

1322 ng/ml(695-1580)13221322 ng/mlng/ml(695(695--1580)1580)

2424

3/163/163/16

5/295/295/29

1/81/81/81/111/111/11

OC - SENSOR FIT FALSE NEGATIVITYOC OC -- SENSOR FIT FALSE NEGATIVITYSENSOR FIT FALSE NEGATIVITY

18.7%18.7%

12.5%12.5%9.1%9.1%

17.2%17.2%

False negativity False negativity -- is is 15.62 %15.62 %(cut(cut--off value 75 ng/ml recommended by the CRC Commission) off value 75 ng/ml recommended by the CRC Commission)

The sensitivity for CRC The sensitivity for CRC -- is 84.38 %is 84.38 %

2525

3/163/163/16

5/295/295/29

1/81/81/81/111/111/11

OC - SENSOR FIT FALSE NEGATIVITYOC OC -- SENSOR FIT FALSE NEGATIVITYSENSOR FIT FALSE NEGATIVITY

18.7%18.7%

12.5%12.5%9.1%9.1%

17.2%17.2%



Kelley L, Swan N, Hughes DJ. - Colorectal Dis. 2013 Sep; 15(9): e512-21An analysis of the duplicate testing strategy of an Irish immunochemical FOBT

colorectal cancer screening programme

KelleyKelley L,L, SwanSwan N,N, Hughes DJHughes DJ.. -- Colorectal Dis. 2013 Sep; 15(9): e512Colorectal Dis. 2013 Sep; 15(9): e512--2121AnAn analysisanalysis of theof the duplicateduplicate testingtesting strategystrategy of anof an IrishIrish immunochemical FOBT immunochemical FOBT

colorectal cancer screening programmecolorectal cancer screening programme

The percentage of unrecognized cancers The percentage of unrecognized cancers -- 17.6%17.6%for one test with cutfor one test with cut--off 75 ng/mloff 75 ng/ml

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CRC TUMOR STAGE & FIT VALUECRCCRC TUMOR STAGE & FIT VALUETUMOR STAGE & FIT VALUE

CRC stage I(n=11)

1656 ng/ml(421-2154)

CRCCRC stage Istage I(n=11)(n=11)

1656 1656 ng/mlng/ml(421(421--2154)2154)

CRC stage II(n=21)

960 ng/ml(453-1639)

CRCCRC stage stage IIII(n=(n=221)1)

960 960 ng/mlng/ml(453(453--1639)1639)

CRC stage III(n=17)

848 ng/ml(37-1554)

CRCCRC stage stage IIIIII(n=1(n=177))

848 848 ng/mlng/ml(37(37--1554)1554)

CRC stage IV(n=15)

720 ng/ml(175-1396)

CRCCRC stage Istage IVV(n=1(n=155))

720 720 ng/mlng/ml(175(175--1396)1396)

Hb ng/ml values are not significantly different

according to tumor stages

Hb ng/ml values Hb ng/ml values are not significantly different are not significantly different

according to tumor stagesaccording to tumor stages

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FOBT - THE PAST20 YEARS WE USED g-FOBT WITH LOW SENSITIVITY BUT THE SAME RELIABILITY IN ALL REGIONS OF THE CZECH REPUBLIC

FOBT FOBT -- THE PASTTHE PAST20 YEARS WE USED g20 YEARS WE USED g--FOBT FOBT WITH LOW SENSITIVITY WITH LOW SENSITIVITY BUT THE SAME RELIABILITY IN ALL BUT THE SAME RELIABILITY IN ALL REGIONS OF THE CZECH REPUBLICREGIONS OF THE CZECH REPUBLIC

FOBT - THE PRESENTIN 2013 WE CHANGED TO i-FOBT, FIT WITH 2-TIMES HIGHER SENSITIVITYBUT DISTINCTLY INCREASING VARIABILITYIN REGIONS OF THE CZECH REPUBLIC

FOBT FOBT -- THE PRESENTTHE PRESENTIN 2013 WE CHANGED TO iIN 2013 WE CHANGED TO i--FOBT, FIT FOBT, FIT WITH WITH 22--TIMES HIGHER SENSITIVITYTIMES HIGHER SENSITIVITYBUT BUT DISTINCTLY INCREASING VARIABILITYDISTINCTLY INCREASING VARIABILITYIN REGIONS OF THE CZECH REPUBLICIN REGIONS OF THE CZECH REPUBLIC

FOBT - THE FUTUREPREMISE - VISIONS - SIX MAIN TASKS

FOBT FOBT -- THE FUTURETHE FUTUREPREMISE PREMISE -- VISIONS VISIONS -- SIX MAIN TASKSSIX MAIN TASKS

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1. TASKANALYSE THE EUROPEAN EXPERIENCES

1. TASK1. TASKANALYSE THE EUROPEAN EXPERIENCES ANALYSE THE EUROPEAN EXPERIENCES

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EUROPEAN EXPERIENCES WITH FITEUROPEAN EXPERIENCES WITH FITEUROPEAN EXPERIENCES WITH FIT

We analysed 175 scientific publications, available on webPublications focusing on CRC screening by FIT Publications published in the last 5 years (2008-2013) The presentation was focused only on studies of European countries

We analysed 175 scientific publications, available on webWe analysed 175 scientific publications, available on webPublications focusing on CRC screening by FIT Publications focusing on CRC screening by FIT Publications published in the last 5 years (2008Publications published in the last 5 years (2008--2013) 2013) The presentation was focused only on studies of European countriThe presentation was focused only on studies of European countrieses

Kocna P.: The European experiences with FIT tests. Proceedings 2nd National Congress on Colorectal Cancer, Prague 2013, 359-369

Kocna P.: The European experiences with FIT tests. Kocna P.: The European experiences with FIT tests. Proceedings 2nd National Congress on Colorectal Cancer, Prague 2Proceedings 2nd National Congress on Colorectal Cancer, Prague 2013, 359013, 359--369369

'EVIDENCE BASED' RECOMMENDATIONS AND EXPERIENCES ARE NOW AVAILABLE'EVIDENCE BASED' RECOMMENDATIONS 'EVIDENCE BASED' RECOMMENDATIONS AND EXPERIENCES ARE NOW AVAILABLEAND EXPERIENCES ARE NOW AVAILABLE

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Recommendations for a colorectal cancer screening programme in Ireland - 12/2008The National Cancer Screening Service Board, Ireland

The Board’s recommendation that the immunochemical faecal occult blood test (iFOBt) which operates on an automated testing platform.

Immunochemical faecal occult blood tests - Evaluation report - November 2009Centre for Evidence-based Purchasing of the NHS Purchasing and Supply Agency.

The OC-Sensor / DIANA analyser is well designed and is the most suitable system for the English bowel cancer screening programme.

A national colorectal cancer screening programme, November 17, 2009The Health Council of the Netherlands

The Committee recommends iFOBT-based screening (OC-Sensor, one faecal sample) once every two years for men and women between fifty-five and seventy-five years old.

Faecal occult blood test-based screening programme. 2009 MayLecco Colorectal Cancer Screening Group

Immunochemical faecal tests (HM-Jack, Kiowa; Japan) were processed by a single central laboratory using an automated reading technique; the positivity cut-off was 100 ng/ml.

Recommendations for a colorectal cancer screening programme in IRecommendations for a colorectal cancer screening programme in Ireland reland -- 12/200812/2008The National Cancer Screening Service Board, IrelandThe National Cancer Screening Service Board, Ireland

The Board’s recommendation that the immunochemical faecal occultThe Board’s recommendation that the immunochemical faecal occult blood test (iFOBt) which blood test (iFOBt) which operates on an operates on an automated testing platform.automated testing platform.

Immunochemical faecal occult blood tests Immunochemical faecal occult blood tests -- Evaluation report Evaluation report -- November 2009November 2009Centre for EvidenceCentre for Evidence--based Purchasing of the NHS Purchasing and Supply Agency.based Purchasing of the NHS Purchasing and Supply Agency.

The OCThe OC--Sensor / DIANA analyserSensor / DIANA analyser is well designed and is the most suitable system for the is well designed and is the most suitable system for the English bowel cancer screening programme.English bowel cancer screening programme.

A national colorectal cancer screening programme, A national colorectal cancer screening programme, November 17, 2009November 17, 2009The Health Council of the NetherlandsThe Health Council of the Netherlands

The Committee recommends iFOBTThe Committee recommends iFOBT--based screening (based screening (OCOC--Sensor, one faecal sampleSensor, one faecal sample) once ) once every two years for men and women between fiftyevery two years for men and women between fifty--five and seventyfive and seventy--five years old. five years old.

Faecal occult blood testFaecal occult blood test--based screening based screening programmprogrammee. . 2009 May2009 MayLecco Colorectal Cancer Screening GroupLecco Colorectal Cancer Screening Group

Immunochemical faecal tests (Immunochemical faecal tests (HMHM--Jack, KiowaJack, Kiowa; Japan) were processed by a single central ; Japan) were processed by a single central laboratory using an laboratory using an automated reading techniqueautomated reading technique; the positivity ; the positivity cutcut--off was 100 ng/mloff was 100 ng/ml..

EUROPEAN EXPERIENCES WITH FITEUROPEAN EXPERIENCES WITH FITEUROPEAN EXPERIENCES WITH FIT

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FOBT - THE FUTUREPREMISE - VISIONS - FIVE MAIN TASKS

FOBT FOBT -- THE FUTURETHE FUTUREPREMISE PREMISE -- VISIONS VISIONS -- FIVE MAIN TASKSFIVE MAIN TASKS



ANALYSE THE EUROPEAN EXPERIENCES

2. TASKHIGHLIGHT QUANTITATIVE FIT

ANALYSE THE EUROPEAN EXPERIENCES ANALYSE THE EUROPEAN EXPERIENCES

2. TASK2. TASKHIGHLIGHT QUANTITATIVE FITHIGHLIGHT QUANTITATIVE FIT

qFIT is 3 times more sensitive and reliable than gFOBT

qFIT analysis is based on specific antibody technique

qFIT on automatic analyzer eliminates subjective evaluation

qFIT allows the quantitative analysis

qFIT could be possible to optimize selecting screening cut-off

qFIT allows comparing the values on a European scale

qFIT may be monitor by quality control system EQAS

qFIT is 3 times more sensitive and reliable than gFOBTqFIT is 3 times more sensitive and reliable than gFOBT

qFIT analysis is based on specific antibody techniqueqFIT analysis is based on specific antibody technique

qFIT on automatic analyzer eliminates subjective evaluationqFIT on automatic analyzer eliminates subjective evaluation

qFIT allows the quantitative analysisqFIT allows the quantitative analysis

qFIT could be possible to optimize selecting screening cutqFIT could be possible to optimize selecting screening cut--offoff

qFIT allows comparing the values on a European scaleqFIT allows comparing the values on a European scale

qFIT may be monitor by quality control system EQASqFIT may be monitor by quality control system EQAS

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HIGHLIGHT QUANTITATIVE FITHIGHLIGHT QUANTITATIVE FITHIGHLIGHT QUANTITATIVE FIT

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At least 50 laboratories in the Czech Republic offers At least 50 laboratories in the Czech Republic offers the quantitative determination of Hb in the stool, the quantitative determination of Hb in the stool,

verified 2times per year by the external quality control system,verified 2times per year by the external quality control system,with sufficient capacity for population screening of CRC.with sufficient capacity for population screening of CRC.

HIGHLIGHT QUANTITATIVE FITHIGHLIGHT QUANTITATIVE FITHIGHLIGHT QUANTITATIVE FIT

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ANALYSE THE EUROPEAN EXPERIENCES HIGHLIGHT QUANTITATIVE FIT

3. TASKCLEARLY DEFINE CUT-OFF POSITIVITY

ANALYSEANALYSE THE EUROPEAN EXPERIENCES THE EUROPEAN EXPERIENCES HIGHLIGHT QUANTITATIVE FITHIGHLIGHT QUANTITATIVE FIT

3. TASK3. TASKCLEARLY DEFINE CUTCLEARLY DEFINE CUT--OFF POSITIVITYOFF POSITIVITY

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Colorectal Disease - 09/2013ColorectalColorectal DiseaseDisease -- 09/09/20120133

Positivity ratePositivity rate(95% CI)(95% CI)

ColonoscopiesColonoscopiesnumbernumber

CRC & adv.CRC & adv.adenomasadenomas

SpecificitySpecificityCRC & AACRC & AA

FIT FIT oneone 6.9% (6.3 6.9% (6.3 -- 7.7%)7.7%) 287287 108108 96.4% (95.7 96.4% (95.7 -- 96.9%) 96.9%)

FIT FIT twotwo 10.2% (9.4 10.2% (9.4 -- 11%)11%) 419 419 149149 94.5% (93.7 94.5% (93.7 –– 95.1%) 95.1%)

9704 kits (2 tests) sent out to residents, 509704 kits (2 tests) sent out to residents, 50--74 years74 yearsreturn rate return rate -- 5023 (52%), positivity ≥ 100 ng/ml: 514 (10.2%)5023 (52%), positivity ≥ 100 ng/ml: 514 (10.2%)419 FIT+ colonoscopy (81.5%) with caecal 419 FIT+ colonoscopy (81.5%) with caecal intubationintubation 402 (96%)402 (96%)CRC found 17 (4.1%), Dukes I + II in 62.5%, 132 advanced adenomaCRC found 17 (4.1%), Dukes I + II in 62.5%, 132 advanced adenomas (31.5%)s (31.5%)

The percentage of unrecognized cancersThe percentage of unrecognized cancers2323..5% for one test with cut5% for one test with cut--off 100 ng/ml and 17.6% with 75 ng/mloff 100 ng/ml and 17.6% with 75 ng/ml

neoplasms, including advanced adenomasneoplasms, including advanced adenomas -- 32% (100 ng/ml) a 30% (75 ng/ml)32% (100 ng/ml) a 30% (75 ng/ml)

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FIT test before colonoscopy FIT test before colonoscopy -- 815 people, two centers (VFN and FTN) 815 people, two centers (VFN and FTN) Comparison of a twoComparison of a two--FIT tests and different cutFIT tests and different cut--off values off values FIT test FIT test -- OCOC--Sensor microSensor micro

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Kovarova JT, Zavoral M, Zima T, Zak A, Kocna P. et al. Biomed Pap 2012 Jun; 156(2): 143 - 150: Improvements in

colorectal cancer screening programmes - quantitative immunochemical faecal occult blood testing - how to set the cut-off for a particular population.

KovarovaKovarova JTJT, Zavoral M, Zima T, Zak A, Kocna P., Zavoral M, Zima T, Zak A, Kocna P. et al. et al. BiomedBiomed Pap 2012 Jun; 156(2): 143 Pap 2012 Jun; 156(2): 143 -- 150150:: ImprovementsImprovements in in

colorectal cancer screeningcolorectal cancer screening programmesprogrammes -- quantitativequantitative immunochemical immunochemical faecal occult blood testing faecal occult blood testing -- howhow to set theto set the cutcut--offoff for afor a particular populationparticular population..

Biomedical Papers - 06/2012Biomedical PapersBiomedical Papers -- 06/201206/2012

Hb Hb cut offcut off -- ng/mlng/ml 5050 7575 100100 125125 150150

SensitivitSensitivityy CRCCRC -- FIT 1FIT 1 88.688.6%%(73.2(73.2 --96.7)96.7)

85.785.7%%(69.7(69.7 -- 95.1)95.1)

85.785.7%%(69.7(69.7 -- 95.1)95.1)

80.080.0%%(63.1(63.1 -- 91.5)91.5)

80.080.0%%(63.1(63.1 -- 91.5)91.5)

SensitivitSensitivityy CRCCRC -- FIT 2FIT 2 88.688.6%%(73.2(73.2 --96.7)96.7)

85.785.7%%(69.7(69.7 -- 95.1)95.1)

85.785.7%%(69.7(69.7 -- 95.1)95.1)

85.785.7%%(69.7(69.7 -- 95.1)95.1)

85.785.7%%(69.7(69.7 -- 95.1)95.1)

SpecificitSpecificityy CRCCRC -- FIT 1FIT 1 87.287.2%%(83.6(83.6 --90.2)90.2)

90.190.1%%(86.8(86.8 -- 92.892.8

91.091.0%%(87.9(87.9 -- 93.6)93.6)

93.093.0%%(90.1(90.1 -- 95.2)95.2)

93.593.5%%(90.6(90.6 -- 95.6)95.6)

81.481.4%%(77.3(77.3––85.0)85.0)

84.784.7%%(80.9(80.9 -- 88.1)88.1)

86.986.9%%(83.3(83.3 -- 90.0)90.0)

89.189.1%%(85.7(85.7 -- 91.9)91.9)SpecificitSpecificityy CRCCRC -- FIT 2FIT 2 90.190.1%%

(86.8(86.8 -- 92.8)92.8)

Recommendation of Czech pilot studyRecommendation of Czech pilot study -- oneone FIT test FIT test with with cutcut--off off valuevalue 75 ng/ml75 ng/ml

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Terhaar sive Droste JS, Oort FA, van der Hulst RW. et al. Cancer Epidemiol Biomarkers Prev; 20(2) February 2011

Higher fecal immunochemical test cutoff levels: lower positivity rates but still acceptable detection rates for early-stage colorectal cancers.

Terhaar sive Droste JSTerhaar sive Droste JS,, OortOort FA, van derFA, van der Hulst RWHulst RW.. et al. et al. Cancer Cancer EpidemiolEpidemiol Biomarkers Biomarkers PrevPrev; 20(2) February 2011; 20(2) February 2011

Higher fecalHigher fecal immunochemical testimmunochemical test cutoff levelscutoff levels:: lowerlower positivitypositivity rates rates but still acceptable detection ratesbut still acceptable detection rates forfor earlyearly--stagestage colorectalcolorectal cancerscancers..

optimization FIT cutoptimization FIT cut--off off 2145 persons > 40 years 2145 persons > 40 years optimization of screening optimization of screening define the minimum age define the minimum age 76 CRC found by colonoscopy76 CRC found by colonoscopy

7575

8080

8585

9090

9595

5050 7575 100100 125125 150150 200200

sensitivitysensitivitysensitivity specificityspecificityspecificity

ng/mlng/mlng/ml

Cancer Epidemiol Biomarkers Prev - 2011CancerCancer Epidemiol Biomarkers PrevEpidemiol Biomarkers Prev -- 20112011

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8585

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5050 7575 100100 125125 150150 200200


ng/mlng/mlng/ml

OC-Sensor Eiken recommended cut-off value 100 ng/mlwith similar sensitivity & specificity approximately 90 %

OCOC--Sensor Eiken recommended cutSensor Eiken recommended cut--off value off value 100 ng/ml100 ng/mlwith similar sensitivity & specificity with similar sensitivity & specificity approximatelyapproximately 90 %90 %

3939

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ng/mlng/mlng/ml

Optimizing cut-off for qiFOBT and indications for colonoscopy:Indicate for colonoscopy, if possible, all pathology,

including 15% of healthy people? The sensitivity could be 93%.

Optimizing cutOptimizing cut--off for qiFOBT and indications for colonoscopy:off for qiFOBT and indications for colonoscopy:Indicate for colonoscopy, if possible, Indicate for colonoscopy, if possible, all pathologyall pathology, ,

including 15% of healthy including 15% of healthy people? The people? The sensitivity could be 93%.sensitivity could be 93%.

Decrease cut-off to 50 ng/mlDecreaseDecrease cutcut--off to 50 ng/mloff to 50 ng/ml

4040

7575

8080

8585

9090

9595

5050 7575 100100 125125 150150 200200


ng/mlng/mlng/ml

Optimizing cut-off for qiFOBT and indications for colonoscopy:Do not indicate for colonoscopy any healthy person,

increase specificity to 93% but reduce the sensitivity by 15%?

Optimizing cutOptimizing cut--off for qiFOBT and indications for colonoscopy:off for qiFOBT and indications for colonoscopy:Do Do not indicatenot indicate for colonoscopy for colonoscopy any healthyany healthy person, person,

increase increase specificity to 93%specificity to 93% but but reduce the sensitivity by 15%reduce the sensitivity by 15%??

Increase cut-off to 200 ng/mlIncreaseIncrease cutcut--off to 200 ng/mloff to 200 ng/ml

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4. TASKCHANGE THE Hb CONCENTRATION UNIT

ANALYSEANALYSE THE EUROPEAN EXPERIENCES THE EUROPEAN EXPERIENCES HIGHLIGHT QUANTITATIVE FITHIGHLIGHT QUANTITATIVE FITCLEARLY DEFINE CUTCLEARLY DEFINE CUT--OFF POSITIVITYOFF POSITIVITY

4. TASK4. TASKCHANGE THE Hb CONCENTRATION UNITCHANGE THE Hb CONCENTRATION UNIT

4242

QuikReadQuikReadQuikRead OC SensorOC SensorOC SensorFOB GoldFOB GoldFOB Gold HM JackHMHM JackJack iT LineariT LineariT Linear

10mg/2ml 10mg/1.7ml 2mg/2ml 10mg/2ml 20mg/1.6ml10mg10mg//2ml 2ml 10mg10mg/1./1.7ml 7ml 2mg2mg//2ml 2ml 10mg10mg//2ml 2ml 20mg20mg/1./1.6ml6ml


VARIABLE SAMPLING DEVICES FOR FIT, WITH DIFFERENTCONCENTRATION OF STOOL IN THE SAMPLING SOLUTIONVARIABLE SAMPLING DEVICES FOR FIT, WITH DIFFERENTVARIABLE SAMPLING DEVICES FOR FIT, WITH DIFFERENTCONCENTRATION OF STOOL IN THE SAMPLING SOLUTIONCONCENTRATION OF STOOL IN THE SAMPLING SOLUTION

12.5 times higher12.5 times higher12.5 times higher

50 100 150 200 250 300 350100

200

300

400

500

600

700

800

900

1000

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Stool concentration in Sentinel sampling tool is1.76 times higher, compare to Eiken samplingStool concentration in Sentinel sampling tool isStool concentration in Sentinel sampling tool is1.76 times higher1.76 times higher, compare to Eiken sampling, compare to Eiken sampling

ng Hb/mlng Hb/mlng Hb/ml

10 20 30 40 50 60 7020

40

60

80

100

120

140

160

180

200

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Re-calculation of measured valuesfrom ng/ml to mg/g og stool

ReRe--calculation of measured valuescalculation of measured valuesfrom ng/ml to from ng/ml to mmg/gg/g ogog stoolstool

mg Hb/g stoolmmg Hb/g stog Hb/g stoolol

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5. TASKMODIFY THE SCREENING RULES

ANALYSEANALYSE THE EUROPEAN EXPERIENCES THE EUROPEAN EXPERIENCES HIGHLIGHT QUANTITATIVE FITHIGHLIGHT QUANTITATIVE FITCLEARLY DEFINE CUTCLEARLY DEFINE CUT--OFF POSITIVITYOFF POSITIVITYCHANGE THE Hb CONCENTRATION UNITCHANGE THE Hb CONCENTRATION UNIT

5. TASK5. TASKMODIFY THE SCREENING RULESMODIFY THE SCREENING RULES

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Terhaar sive Droste JS, Oort FA, van der Hulst RW. et al. Cancer Epidemiol Biomarkers Prev; 20(2) February 2011

Higher fecal immunochemical test cutoff levels: lower positivity rates but still acceptable detection rates for early-stage colorectal cancers.

Terhaar sive Droste JSTerhaar sive Droste JS,, OortOort FA, van derFA, van der Hulst RWHulst RW.. et al. et al. Cancer Cancer EpidemiolEpidemiol Biomarkers Biomarkers PrevPrev; 20(2) February 2011; 20(2) February 2011

Higher fecalHigher fecal immunochemical testimmunochemical test cutoff levelscutoff levels:: lowerlower positivitypositivity rates rates but still acceptable detection ratesbut still acceptable detection rates forfor earlyearly--stagestage colorectalcolorectal cancerscancers..

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ng/mlng/mlng/ml

Cancer Epidemiol Biomarkers Prev - 2011CancerCancer Epidemiol Biomarkers PrevEpidemiol Biomarkers Prev -- 20112011

Optimization FIT cutOptimization FIT cut--off off 2145 persons > 40 years 2145 persons > 40 years Optimization of screening Optimization of screening define the minimum age define the minimum age 76 CRC76 CRC found by colonoscopyfound by colonoscopy

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Crotta S, Segnan N, Paganin S, et al. Clin Gastro.Hepato. 2012;10(6):633-638High rate of advanced adenoma detection in 4 rounds of colorectal cancer

screening with the fecal immunochemical test.

CrottaCrotta S,S, SegnanSegnan N,N, PaganinPaganin S, S, et al. Clin Gastro.et al. Clin Gastro.HepatoHepato. 2012;10(6):633. 2012;10(6):633--636388High rateHigh rate ofof advanced adenoma detectionadvanced adenoma detection in 4in 4 roundsrounds of colorectal cancer of colorectal cancer

screeningscreening withwith thethe fecalfecal immunochemical test.immunochemical test.

Clinical Gastroenterol Hepatol. - 06/2012Clinical Gastroenterol HepatolClinical Gastroenterol Hepatol. . -- 06/201206/2012

Local studies with 9,800 inhabitants, 3,145 aged 50Local studies with 9,800 inhabitants, 3,145 aged 50--74 years74 yearsFIT test OCFIT test OC--Sensor, 100 ng/ml, performed 2001Sensor, 100 ng/ml, performed 2001--20032003--20062006--20082008Participation in four cycles from 56% to 63%, 48.1% of all 4 cycParticipation in four cycles from 56% to 63%, 48.1% of all 4 cyclesles

CyCyccllee 20012001 20032003 20062006 20082008

InvitedInvited 29592959 25662566 20562056

ParticipatedParticipated 21612161 15201520 971971 713713

33 33 ((3,4%3,4%))

1010

11862862

36 36 ((5,1%5,1%))

1212

FIT pFIT poossitivititivityy 92 92 ((4,3%4,3%)) 62 62 ((4,1%4,1%))

CRCCRC++AAAA detecteddetected 3535 1188

Local studies with 4 cycles lasting 8.5 year with the participatLocal studies with 4 cycles lasting 8.5 year with the participation ion of 48% of the population in all cycles of 48% of the population in all cycles

Screening Screening -- quantitative FIT with cutquantitative FIT with cut--off of 100 ng/mloff of 100 ng/ml

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DETECTED COLORECTAL CANCERSDETECTED COLORECTAL CANCERSDETECTED COLORECTAL CANCERS


7575 292292 7.057.05 %%

> 1000> 1000 4747 1.131.13 %%


7575 11287287 19.6219.62 %%

> 1000> 1000 331111 4.744.74 %%

AGE 50 – 90 YEAR ( n = 4145 )AGE 5AGE 50 0 –– 990 0 YEARYEAR ( n = 4145 )( n = 4145 ) AGE 50 – 90 YEAR ( n = 6561 )AGE AGE 50 50 –– 90 90 YEARYEAR ( n = ( n = 66561 561 ))

Patients of the Center for Preventive Care & GPs

Patients of the Center for Patients of the Center for Preventive Care & GPsPreventive Care & GPs

Patients specialized hospital clinics outpatient and inpatients

Patients specialized hospital clinics Patients specialized hospital clinics outpatient and inpatientsoutpatient and inpatients

Detected CRC – 11/64DetectedDetected CRCCRC –– 1111/64/64 Detected CRC – 53/64DetectedDetected CRCCRC –– 5353/64/64

Kocna P., Májek O., Blaha M., Zima T., Dušek L.: Characteristics of colorectal cancer detected by quantitative faecal haemoglobin test in hospital opportunistic screening.

WorldLab 2014, June, Istanbul

Kocna P., Májek O., Blaha M., Zima T., Dušek L.:Kocna P., Májek O., Blaha M., Zima T., Dušek L.: CharacteristicsCharacteristics of colorectal cancer of colorectal cancer detecteddetected byby quantitativequantitative faecalfaecal haemoglobinhaemoglobin test intest in hospital opportunistichospital opportunistic screening.screening.

WorldLabWorldLab 2014, June, Istanbul2014, June, Istanbul

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ANALYSE THE EUROPEAN EXPERIENCES HIGHLIGHT QUANTITATIVE FITCLEARLY DEFINE CUT-OFF POSITIVITYCHANGE THE Hb CONCENTRATION UNIT

5. TASKMODIFY THE SCREENING RULES

ANALYSEANALYSE THE EUROPEAN EXPERIENCES THE EUROPEAN EXPERIENCES HIGHLIGHT QUANTITATIVE FITHIGHLIGHT QUANTITATIVE FITCLEARLY DEFINE CUTCLEARLY DEFINE CUT--OFF POSITIVITYOFF POSITIVITYCHANGE THE Hb CONCENTRATION UNITCHANGE THE Hb CONCENTRATION UNIT

5. TASK5. TASKMODIFY THE SCREENING RULESMODIFY THE SCREENING RULES

-- could we change screening age limits could we change screening age limits since 40 yearsince 40 year ??-- could we include could we include annually FIT testannually FIT test even after colonoscopy ?even after colonoscopy ?-- could we increase number of FIT tested subjects including could we increase number of FIT tested subjects including indicationsindications

from specialized hospital clinicsfrom specialized hospital clinics -- diabetology, cardiology etc ?diabetology, cardiology etc ?

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ANALYSE THE EUROPEAN EXPERIENCES HIGHLIGHT QUANTITATIVE FITCLEARLY DEFINE CUT-OFF POSITIVITYCHANGE THE Hb CONCENTRATION UNITMODIFY THE SCREENING RULES

6. TASKINCREASE EDUCATION UNIVERSALLY

ANALYSE THE EUROPEAN EXPERIENCES ANALYSE THE EUROPEAN EXPERIENCES HIGHLIGHT QUANTITATIVE FITHIGHLIGHT QUANTITATIVE FITCLEARLY DEFINE CUTCLEARLY DEFINE CUT--OFF POSITIVITYOFF POSITIVITYCHANGE THE Hb CONCENTRATION UNITCHANGE THE Hb CONCENTRATION UNITMODIFY THE SCREENING RULESMODIFY THE SCREENING RULES

6. TASK6. TASKINCREASE EDUCATION UNIVERSALLYINCREASE EDUCATION UNIVERSALLY

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3/163/163/16

5/295/295/29

1/81/81/81/111/111/11

18.7%18.7%

12.5%12.5%9.1%9.1%

17.2%17.2%







The percentage of unrecognized cancers The percentage of unrecognized cancers -- 17.6%17.6%for one test with cutfor one test with cut--off 75 ng/mloff 75 ng/ml

EDUCATION ON IMPORTANCE OF FIT VALUESEDUCATIONEDUCATION ONON IMPORTANCEIMPORTANCE OF FITOF FIT VALUESVALUES

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Man 66 year (born 1946)Man 66 year (born 1946)29.4.200929.4.2009 -- FIT: 0 ng/mlFIT: 0 ng/ml8.8.20118.8.2011 -- FIT: FIT: 1355 ng/ml1355 ng/ml

NO reactionNO reaction11.7.201211.7.2012 -- FIT:FIT: 1854ng1854ng/ml/ml14.8.2012 14.8.2012 -- colonoscopy, sigmoid CRCcolonoscopy, sigmoid CRC6.9.2012 6.9.2012 -- tumour resection, stage 3tumour resection, stage 3FIT FIT -- surgery time: surgery time: 12.96 months12.96 months

ManMan 72 72 yearyear ((born born 1941)1941)13.5.201013.5.2010 -- FIT: FIT: 00 ng/mlng/ml14.11.201214.11.2012 -- FIT: FIT: 741741 ng/mlng/ml

NO NO reactionreaction5.3.20135.3.2013 -- FIT: FIT: 1637 ng/ml1637 ng/ml10.4.2013 10.4.2013 -- ccoloolonoscnoscopopyy, , sigmoidsigmoid CRCCRC13.5.2013 13.5.2013 -- tumotumouur resection, stage 3r resection, stage 3FIT FIT -- surgery timesurgery time: : 5.92 months5.92 months

Kocna P., Májek O., Blaha M.: Clinical and epidemiological importance of analyzing laboratory data with the data source I-COP.

Sborník Medsoft 2014 - March 25; 110-122 on-line: http://creativeconnections.cz/medsoft/2014.html

Kocna P.,Kocna P., MájekMájek O.,O., BlahaBlaha M.: Clinical and epidemiological importance M.: Clinical and epidemiological importance of analyzing laboratory data with the data source Iof analyzing laboratory data with the data source I--COP.COP.

Sborník MedsoftSborník Medsoft 2014 2014 -- March 25; 110March 25; 110--122 122 onon--line: http://line: http://creativeconnectionscreativeconnections..czcz//medsoftmedsoft/2014.html/2014.html

Two cases with Two cases with FIT value 0 ng/ml and CRCFIT value 0 ng/ml and CRC

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FIT value 0 ng/ml does not mean, that there is no cancer

Quantitative FIT with sensitivity 85% does not recognize 15% of CRC

Repeated FIT screening, annually, are very important

FIT value more than 1000 ng/ml being almost reliably indicates cancer and colonoscopy should be performed as soon as possible

FIT value 0 ng/ml does not mean, that there is no cancerFIT value 0 ng/ml does not mean, that there is no cancer

Quantitative FIT with sensitivity 85% does not recognize Quantitative FIT with sensitivity 85% does not recognize 15% of CRC15% of CRC

Repeated FIT screening, annually, are very importantRepeated FIT screening, annually, are very important

FIT value more than 1000 ng/ml being almost reliably FIT value more than 1000 ng/ml being almost reliably indicates cancer and colonoscopy should be indicates cancer and colonoscopy should be performed asperformed as soon as possiblesoon as possible


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ANALYSE THE EUROPEAN EXPERIENCES

HIGHLIGHT QUANTITATIVE FIT

CLEARLY DEFINE CUT-OFF POSITIVITY

CHANGE THE Hb CONCENTRATION UNIT

MODIFY THE SCREENING RULES

INCREASE EDUCATION UNIVERSALLY

ANALYSE THE EUROPEAN EXPERIENCES ANALYSE THE EUROPEAN EXPERIENCES

HIGHLIGHT QUANTITATIVE FITHIGHLIGHT QUANTITATIVE FIT

CLEARLY DEFINE CUTCLEARLY DEFINE CUT--OFF POSITIVITYOFF POSITIVITY

CHANGE THE Hb CONCENTRATION UNITCHANGE THE Hb CONCENTRATION UNIT

MODIFY THE SCREENING RULESMODIFY THE SCREENING RULES

INCREASE EDUCATION UNIVERSALLYINCREASE EDUCATION UNIVERSALLY

THANK YOU FOR YOUR ATTENTIONTHANK YOU FOR YOUR ATTENTION

Quantitative FIT tests in the Czech Republic Past, present...

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