Copyright © 2013 Quintiles SPONSOR: Roche PROTOCOL: WO29217 US Region (AP6396, Canada), (AP6397,...

Copyright © 2013 Quintiles

SPONSOR: Roche

PROTOCOL: WO29217

US Region (AP6396, Canada), (AP6397, US)Version 01 10 July 2014

(English)

FLOWCHART

Roche – WO29217

Version 0110 July 2014 of 11

Roche

PROTOCOL: WO29217

INDICATION: Malignant Tumor of Breast

c a a b

Screening Visit Baseline

Pre-dose Cycle 5 Day 1

Cycle 8 Day 1 Surgery

Pre-dose Cycle 14

Day 1

Pre-dose Cycle 18

Day 1

Study Comp/Early

Term Early Term Unsch/Retest

Mandatory Primary Tumour Tissue Sample (Material Supply only) l

Optional Surgical Tumour Tissue Sample (Material Supply only) l

Mandatory Serum Sample l(3) l(3) l(3) l(3) l(3) l(3) l(3)

Key l Scheduled Testing

m Unscheduled/Retest

l(3) 3 Aliquots.

a Optional Visit

b Optional Visit

c Sample to be collected after Cycle 8/prior to Surgery

SCHEDULE OF TESTING

Roche – WO29217


* When using a “butterfly” blood collection set for venipuncture and a coagulation (citrate) tube is the first specimen tube to be drawn, a discard tube should be drawn first. The discard tube must be used to fill the blood collection set tubing’s “dead space” with blood but the discard tube does not need to be completely filled. This important step will ensure proper blood-to-additive ratio. The discard tube should

be a non-additive or coagulation tube.*

Source: BD Vacutainer® Order of Draw for Multiple Tube Collections. (Reflects change in CLSI recommended Order of Draw (H3-A5, Vol 23, No 32, 8.10.2)

Recommended Order of Draw

Order of Draw Container/Top Color Additive

First

Last

Culture Bottles Multiple See Bottle Label

Light Blue Citrate

Red/Black, Gold Gel, SST, Serum

Red No Gel, Serum

Light Green, Green/Gray Heparin

Lavender, Pink K2 EDTA, K3 EDTA

Gray Sodium Fluoride

Tubes with other Additives

Light Yellow Citrate ACD

Roche – WO29217


Visit TestsCollection

TubesInstructions Tubes to be

sent backShipping

Temp.Shipping

Frequency

Baseline

Pre-dose C5 D1

C8 D1

Pre-dose C14 D1

Pre-dose C18-D1

Study Completion /

Early Termination

Visit

Unsch/Retest

• ATA to Pertuzumab

• Pertuzumab Concentration

• RCR Serum

8.5ml SST

• Draw 8.5ml of blood into the SST tube, filling completely• Invert tube 8-10 times.• Allow to clot for 30 minutes at room temperature.• Within 60 minutes of blood collection, centrifuge at 1500 – 2000g for 15 minutes at 4 degrees Celsius. (same conditions apply if no cool centrifuge is available)• Within 20 minutes of centrifugation, equally aliquot the Serum into each of the 2ml Cryovial storage tubes (labelled Cryovial A, Cryovial B and Cryovial C). There should be approx 1ml of serum in each of the cryovial tubes. • Freeze the 2mL aliquot tubes at -70 degrees Celsius. If not available, store at -20 degrees Celsius then ship within 48 hours of collection.•Ship the 3 cryovial storage tubes on the day of collection, along with the completed requisition form in a frozen condition to Qlab.

Frozen (dry ice)

3 x 2ml Cryovial Storage Tubes

(Approx 1ml Serum into

Cryovial A, B & C)

Daily to QLAB Using

FedEx

Quintiles Ltd.1600 Terrell Mill RoadSuite 100Marietta, GA 30067United States

Mandatory Serum

Samples

Roche – WO29217


Visit TestsCollection Container

Instructions Container to be sent back

Shipping Temp.

Shipping Frequency

Primary Tumour Block Ambient

Screening

• Obtain a tumour block (biopsy material) that contains a representative sample of the tumour.• Fixation of tumor: 10% neutral buffered formalin (equivalent to 4% formaldehyde solution) for 6-72 hours for biopsy specimens.• Tissues should be dehydrated in a series of alcohols, followed by infiltration by melted paraffin held at no more than 60 degrees Celsius.• For pre-treatment core biopsies, at least one core should be sent, which is truly representative of the invasive tumour.• Write patient screening number on the white label for blocks that is attached to the mini-grip bags. Patient screening number: 9 digits.• Put the block in the provided labelled mini-grip bag and write the Block-ID.• Complete the Requisition Form for IED with the necessary information. • Wrap the mini-grip bag with tumour block in the provided shipment material: Either bag or drum as provided by the courier.• Ship the block within 48 hours along with the completed requisition form in an ambient condition (IED).

60mL Yellow Cap Container

Ship directly to IEO lab Using

MarkenStefania Andrighetto Department of PathologyIstituto Europeo di OncologiaVia Ripamonti 43520141 Milan - Italy


Roche – WO29217



Instructions Slides to be sent back

Shipping Temp.

Shipping Frequency

Primary Tumour Slides Ambient

Screening

Ship directly to IEO lab

within 48 hours of

slides being cut using Marken

Slide Holder Stefania Andrighetto Department of PathologyIstituto Europeo di OncologiaVia Ripamonti 43520141 Milan - Italy

•Obtain a tumour block (biopsy material) that contains a representative sample of the tumour.•Fixation of tumor: 10% neutral buffered formalin (equivalent to 4% formaldehyde solution) for 6-72 hours for biopsy specimens.•Tissues should be dehydrated in a series of alcohols, followed by infiltration by melted paraffin held at no more than 60 degrees Celsius.•Cut 15 slides from the selected tumour block on the microtome. Slide sections should be 4 um thick. Float the sections in a protein-free (e.g. triple distilled) water bath at 40 degrees Celsius.•Mount each section on the coated side of the slides (use only positively charged SUPERFROST Plus glass MICRO SLIDES). Mount only one section per slide and number the slides in the order the sections were cut. Air-dry the slides for at least 2 hours.•Write the patient screening number on the labels on the slide case. Patient screening number: 9 digits• Complete the Requisition Form for the (IED) with the necessary information. •Wrap the slide cases in the provided shipment material: Either bag or drum as provided by the courier.•Ship the fresh cut slides within 48 hours along with the completed requisition form in an ambient condition to (IED).


Roche – WO29217



Instructions Container to be sent back

Shipping Temp.

Shipping Frequency

Optional Surgical Tumour Tissue Sample

AmbientSurgery


Monthly to IEO lab Using

Marken

•Obtain a tumour block (surgical specimen) that contains a representative sample of the tumour.•Fixation of tumor: 10% neutral buffered formalin (equivalent to 4% formaldehyde solution) for 6-72 hours for surgical specimens.•Tissues should be dehydrated in a series of alcohols, followed by infiltration by melted paraffin held at no more than 60 degrees Celsius•For surgical specimens please submit at least 5 mm invasive tumour in the block.•Write patient on the white label for blocks that is attached to the mini-grip bags. Patient enrollment number: 4 •Put the block in the provided labelled mini-grip bag. •Wrap the mini-grip bag with tumour block in the provided shipment material: Either bag or drum as provided by the courier•Ship the block within 1 month along with the completed requisition form in an ambient condition to IED •Record processing, storage and shipping in the log provided.


Stefania Andrighetto Department of PathologyIstituto Europeo di OncologiaVia Ripamonti 43520141 Milan - Italy

Roche – WO29217


Diagnostic Frozen Shipper

1. Select the appropriate protocol visit – specific kit. 4. Place the SSB & the dry ice (6lb or 3kg) into bottom of shipper. For batch shipping, multiple SSB’s or a cryobox (if supplied) may be placed in one frozen shipper.

2. COMPLETE the entire requisition form. Collect the sample(s). Centrifuge & transfer to appropriate transfer tube(s), if required.

5. Place the foam lid on foam – lined shipper. Place the IATA contents card on top of the foam shipper & secure shipper flaps with tape. Attach air waybill to outside of box. Indicate amount of dry ice & shipper information on outside shipper label.

3. Place tubes into the absorbent tube holder. Place urine tube(s) in plastic bag(s), if applicable. Place tube holder & urine tube(s) & cryobox (if supplied) into the front pouch of the Specimen Shipping Bag (SSB), & place requisition form into the back pouch. Seal bag.

Front Back

Roche – WO29217


1. Select the appropriate protocol visit – specific kit & COMPLETE the entire requisition form.

4. Place the foam liner into the box, as shown in photo.

2. Collect the tumor & transfer to appropriate transfer container. Place container/slides into the appropriate shipping bag.

5. Then put Bubble Wrap Bag into Foam Lined Shipper with IATA contents card. Attach air waybill to outside of box.

3. Place sealed SSB between layers of Gel Wrap then into Bubble Wrap Bag. Seal bag. Note, two SSBs can be shipped in one bubble wrap envelope per shipper.

Diagnostic Ambient Shipper

Roche – WO29217


Study Contacts

Quintiles Laboratories Investigator ServicesUS Toll Free: 800-676-8452

8 AM – 8 PM (Eastern Time) Monday – Friday9 AM – 6 PM (Eastern Time) Saturday

Courier InformationFederal Express1-800-463-3339

Call to arrange pick up

Infosario Portal [email protected]

QLAB Project ManagerDavid O’Brien

Direct line: [email protected]

QLAB Sr. Project CoordinatorDenise Sheppard

Direct line: [email protected]

Roche – WO29217


Copyright © 2013 Quintiles SPONSOR: Roche PROTOCOL: WO29217 US Region (AP6396, Canada), (AP6397,...

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