Tissue Issue

Adekunle Raji

Director of Cooperative Group Studies

& BIOREPOSITORY

Pathology Core Facility - RHLCCC

Northwestern University

ACCR

July 20, 2012

Tissue Issues

Tissue for research, banking and clinical trials

Tissue types

Human subject research

Non-human subject research

Acquiring tissue from NMH

Acquiring tissue from Pathcore ( NU )

Tissue for what ?

Standard of Care – Highest Priority

Clinical Investigations - Chemo sensitivity physician-

patient driven.

Therapeutic Clinical Trials – Integral biomarker for

Tx. assignment, eligibility, evaluability.

Laboratory Correlates to Trials - integrated

biomarkers – objective with certain end-points.

Stand alone laboratory Studies -

Disease-Driven Program BIOREPOSITORIES

What Are Tissue ?

SPECIMENS:

Blood, urine, lavage, aspirate, saliva, hair, nail,

biopsy and resected tissue, etc, that are obtained

from patients – DIRECT CONTACT

By-products such as serum, plasma, DNA, RNA,

proteins, cell culture, cell blocks, tissue blocks,

tissue sections, stained tissue slides,etc are

generated from the above – INDIRECT CONTACT

Blood & Fluid Collection methods

Routine vacutainers EDTA, SST, heparin tube, redtop, ACD, etc.

Special vacutainers Paxgene DNA, RNA, CTAD, P100, P700, CellSave etc

Obtained from a tissue bank –

stored/prospectively.

Special shipping and handling – IATA+ www.bd.com www.qiagen.com

w ww.veridex.com www.gbo.com

Biopsy/ Resected Tissue Collection

NMH Operating policy and procedures. Neutral Buffered formalin, fresh, and others.

Outpatient clinic policy and procedures. Neutral Buffered formalin, fresh, and others.

Trial Specific as described in IRB approve

protocol and instructional manual. Saline buffer, RNAlater, RPMI, LN2, Dry-Ice, etc.

SURGICAL RESECTION TISSUE BLOCK

Striking a balance

Is there enough ?

Patient Care need

Global Study need

Local Institution need

Study Feasibility

Site participation - resource availability.

Self Qualification – what are the policy here at NMH.

Local review and feasibility study – cost etc.

Local In-service – Departments and section endorsement/involvement.

Sponsor Clarification and confirmation – agreement.

Initiate then Implement -

Pathology Department

Institutional Review Board

Study require tissue submission.

Must engage pathologists and pathology

departments. Information exchange, QA

Must understand pathology department policy. Local dept.

Referring Institutions

Chicagoland Area hospital Path Dept.

Federal and State Agencies

( Regulation and Laws )

Code of Federal Register – CFR ( Federal Laws )

Code of State Regulations – CSR ( State Laws )

US Department of Health and Human Services – HHS

Center for Medicare & Medicaid Services – CMS 493.1105

US Food and Drug Administration – FDA

Office of Civil Rights - OCR

Office of Human Research Protection - OHRP

Other Governing Agencies

Clinical Laboratory Improvement Amendment – CLIA 493.1105

The Joint Commission - formerly JCAHO

College of American Pathologists - CAP

COLA – Accrediting agency

Study Compliance

Full understanding of roles.

Full collaboration.

Research Regulations and Certification

( Regulations and Laws )

Office For Human Research Protection

Federal Wide Assurance

HHS human subject protection regulations and policies require that

any institution engaged in non-exempt human subjects research

conducted or supported by HHS must submit a written assurance of

compliance to OHRP. The Federalwide Assurance (FWA) is the only

type of new assurance accepted and approved by OHRP. FWAs also

are approved by the Office for Human Research Protections (OHRP) for

federalwide use, which means that other federal departments and

agencies that have adopted the Federal Policy for the Protection of

Human Subjects (also known as the Common Rule) may rely on the

FWA for the research that they conduct or support.

The Issue is the Tissue

Anatomic Pathology Checklist

ANP 12500

Record Retention Phase II. Paraffin blocks

– 10 years (subject to Note 2, below)

College of American Pathologist –

CAP key provisions

1. The written consent of the patient is obtained. For laboratories subject to U.S. regulations, the consent must include

formal authorization in accordance with the requirements of HIPAA, if identifiable patient information is released.

2. The laboratory retains sufficient blocks to support the diagnosis for the full 10-year

period.

3. Provision is made for retrieval by the laboratory of any blocks or material that remain

after use in research, if the blocks or material are needed for diagnostic, legal, or other

legitimate purposes.

4. The laboratory meets other relevant requirements including but not limited to the requirements of the institution, the

directives of any applicable institutional review board(IRB) or similar entity; and state and local laws and regulations.

College of American Pathology – CAP

( Policy Standards )

MULTIPLE TUMOR BLOCKS FROM A SURGICAL RESECTION

S

FROM SURGICAL RESECTION.

Breast Protocols in general. ( PACCT1/Tailorx, E5103 ) One Block of invasive cancer.

One block of negative margin.

One block of positive node.

GI Protocols in general. ( E5202, E5204, E3200 ) One block of cancer

One block of distal margin

One block of normal mucosa

GU Protocols in general. ( E2805, E5803, E1808 ) One block of cancer

One block of adjacent normal

FROM SURGICAL RESECTION.

FROM SURGICAL RESECTION.

Melanoma - One tumor block

Lymphoma – One tumor block

Lung Cancer – One tumor block

Head and Neck – One tumor block

Brain cancer – One tumor block

Blocks vs. Slides

In this era of targeted therapy, unstained slides are

becoming useless due to their limited use, and loss of

protein and molecular markers due to aging.

Selection of cases for novel testing in extended laboratory

studies are generally restricted to cases with blocks due to

questionable quality exhibited by unstained slides

Therefore if you choose to submit unstained slides,

your patients and their data may not be included in this important

lab studies i.e. E2197, E3200, E2288, E1199, E2197, E2603,

E2805, E5202, PACCT1, etc, etc.

Blocks vs. Slides

Alternate submission for now.

Where are these tissue?

NU – Pathology Core Facility

NMH – Tissue Archives

DERMATOLOGY – Tissue Archives

Acquiring Tissue

Pathology Core BIOREPOSITORY – Prostate, Breast, Colon,

brain, Lymphoma, CLL.

Manager: Francis de Leon

biorepository@northwestern.edu

NMH Archives – Generally tissue blocks and slides on

all diseases. Clinical Specimen Review Committee

Technical Coordinator: Melissa Launhardt,

mlaunbar@nmh.org

Non-human Subject Research

OPRS – IRB makes determination.

Human sample use

De-identified – not by the researcher. (no PHI).

On the shelves, or prospectively through an

established repository/bank.

Investigators is unable to ascertain.

Questions

Adekunle Raji

a-raji@northwestern.edu

Tel. 312-908-9595

Pager 312-695-5802