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NSABP Division of Pathology Director: Soonmyung Paik, MD (soon.paik@nsabp.org)      Phone: 412-359-5013      Fax: 412-359-3239 Data Manager: Melanie Finnigan (melanie.finnigan@nsabp.org)      Phone: 412-359-3312      Fax: 412-359-3239 Histotechnologists: Theresa Oeler (toeler@wpahs.org) William Hiller (bill.hiller@nsabp.org) Contents 1. Overview and Scope of Operation 2. NSBAP Tissue Bank 3. NSABP Tissue Bank Policy 4. Recent Publications from NSABP Pathology Section 5. Links to Other Sites of Interest for Molecular Pathology of Breast and Colon Cancer 6. Important Information About Submitting Blocks to the NSABP 1. Overview and Scope of Operation The NSABP (National Surgical Adjuvant Breast and Bowel Project) Tissue Bank is the central repository of tissue samples (stained and unstained slides, tissue blocks, and frozen tissue specimens) collected from clinical trials conducted by the NSABP. The NSABP Tissue Bank is located at the NSABP Division of Pathology laboratory at Allegheny General Hospital. The main scientific aim of the NSABP Division of Pathology is to identify, characterize, and verify markers that predict response to specific therapeutic modality. To achieve this aim, the lab collects the tumor and adjacent normal tissues from cancer patients enrolled into the NSABP trials through its membership institutions, and maintain these valuable materials with clinical follow-up information and distribute them to qualified approved investigators. Currently specimens from over 50,000 cases of breast and colon cancer are stored and maintained at the Division. The pathology section conduct studies to identify, characterize, and verify markers that predict response to specific therapeutic modality using collected materials. In addition, delinked sections are also distributed to qualified outside investigators. Back to the contents 2. NSABP Tissue Bank *note: NCI Cooperative Breast Tissue Registry Database (investigators are recommended to visit this site before requesting tissue from NSABP Tissue Bank) http://resresources.nci.nih.gov/categorydisplay.cfm?catid=6 Logistics of Tissue Procurement Currently tissue blocks are mandatory submission items for most of the NSABP trials. The tissue specimens are initially sent in to NSABP Biostatistics Center at University of Pittsburgh labeled with the NSABP Study Number - patient identifier used for tracking the enrolled patients in the NSABP trials. At the Biostatistical Center they are logged into the computer datafile. In order to conduct quality control for the materials received, copies of the pathology report and a data form (form D-1) are also collected. The database maintained at the Biostatistical Center does keep patient names for clinical data collection purposes. However none of the personnel from the Pathology Section has access to any of the data files or computers at the Biostatistical Center. Materials are then batched and shipped to the Tissue Bank Laboratory together with copy of pathology reports and forms with patient name erased. Upon receipt of materials a new serial number is assigned and a computer file that does not contain patient identity is generated. The only link to patient identity is NSABP Study number which is kept for the purpose of linking clinical follow up data at the end of the study. This is also necessary to identify correct material to send back to the institutions when they request the return of the materials for the purpose of patient care. Nature of the Materials in the NSABP Tissue Bank Paraffin embedded tumor specimens are available from NSABP trials as indicated below. We currently do not bank frozen tissues. What Kinds of Information are Associated with the Banked Tissue Blocks? All blocks are from patients enrolled in prospective NSABP treatment protocols and complete clinical follow up information is available as well as demogaphic information. What Kind of Materials do we Provide to Collaborating Investigators? Unstained tissue sections of 4 micrometer thickness are provided to the investigators in a blinded study format. Who has the Access to the Banked Tissue Blocks? Any investigators with novel projects that conform to the research goals of NSABP may apply for the tissue. Please refer to the NSABP Tissue Bank Policy to determine if your project conforms to these goals. Specifically NSABP does not provide tissues for germline genetic studies, since we do not have the patient consent to support such studies. Is there a Specific Form that I have to use to Apply for Tissue Blocks? Yes. You must submit an NIH grant format application to request tissue blocks, excluding the budget page. If you are a funded investigator, you may send a copy of the original grant. Is there a Specific Deadline for Application? Yes. We have two application deadlines each year, March 1st and September 1st, with the decision for the distribution of tissue made within 6 months. How Long Does the Approval Process Take? You will be notified of the decisions within 6 months of the submission deadline. What is the Chance of Approval? Please refer to NSABP Tissue Bank Policy for prioritization information. Priority is given to NSABP membership institutions who regularly submit tissue blocks. Since our tissue resources are extremely limited, we are able to collaborate with only those investigators with novel reagents and promising preliminary data who seek to verify their initial observations in a large scale study. All the routine markers are examined at the Pathology Section. We specifically do not provide sections to commercial reference labs. Does NSABP Fund the Collaborative Projects? No. It is the investigator's responsibility to seek proper funding before contacting NSABP for tissue blocks. We do not provide tissues to unfunded investigators. However, for novel projects we may provide letters of support for new or continuing grant applications. Is there a Contact Person in the NSABP Pathology Section who is Available for Consultation Before Sending in the Application? Yes. Please e-mail (soon.paik@nsabp.org) or Fax (412-359-3239) Dr. Soon Paik. Please do not call. Back to the contents 3. NSABP Tissue Bank Policy Statement (approved by CTEP, NCI, NIH, 1996) I. Maintenance of Patient Biologic Specimens All slides are stored in slide file cabinets in a locked storage room at the NSABP Pathology Section. All blocks received before 1996 are stored in blocks cabinets in a locked storage room at the NSABP Pathology Section. All tissue blocks received since 1997 are stored in locked refrigerators at the NSABP Pathology Section. All materials are logged into a computer database at the Biostatistical Center and at the NSABP Pathology Section. No one except NSABP Pathology Section and Biostatistics personnel should have access to this database. No tissue blocks are to be completely depleted. At least two representative unstained section from each used block needs to be stored in a permanent file. II. Distribution of the Biological Specimens Application Process Application deadlines: We will have two application deadlines each year, March 1st and September 1st, with the decison for the distribution of tissue made within 6 months. Application: Any investigators who desire to access NSABP tissue bank cases must apply to the NSABP Operations Center. Availability of the biological samples and information concerning the application and review process will be announced through the NSABP home page on the Internet. Review Process Applications are reviewed by an internal review committee at the NSABP Operations Center. The review committee should include the Chairman of the NSABP, the head of the Biostatistics Center, and the director of the Pathology Section. When scientific expertise outside the internal committee is required, the NSABP Scientific Advisory Board or its Genetic Advisory Committee is consulted for advise. Review Criteria The proposals are given priority scores according to 1) scientific merit, and 2) membership status including compliance of the institution for tissue block submission. Scientific merit is judged by 1) importance of hypothesis for future diagnosis and treatment of breast or colorectal cancer, 2) originality of the project, 3) credibility of the investigator, and 4) exisiting peer reviewed funding. In general tissue distribution will be restricted to investigators with novel findings or novel reagents. We will not provide tissues to investigators proposing to screen a large number of samples with widely avaliable reagents/methods. Most importantly, however, all proposals need to conform to the overall scientific direction of NSABP, which is verification/discovery of therapeutic response variables. This strict guideline is designed to limit the use of NSABP material only for validation studies or state-of-art pilot studies. Mechanism of Distribution and Protection of Confidentiality Blocks will be always kept in the NSABP Pathology Section storage space and will never be sent to individual investigators. Only sections prepared to the investigators' specifications will be provided; these will be coded with pathology section ID numbers which differ from NSABP study numbers. There is no way that individual investigators can back track the ID of the patients involved. III. Utilization of Specimens to be Obtained from Patients on Intergroup Trials All tissue blocks from patients on Intergroup trials are to be stored in a separate cabinets. Intergroup materials are readily available to investigators with proper approval from Intergroup, if there is no direct sceintific conflict with on-going NSABP studies. Back to the contents 4. Recent Publications Fisher ER, Costantino J, Fisher B, Palekar AS, Paik SM, Suarez CM, Wolmark N for NSABP Collaborating Investigators: Pathologic findings from the NSABP Protocol B-17. Five year observations concerning lobular carcinoma in situ. Cancer, 78:1403-1416, 1996 Fisher ER, Dignam J, Tan-Chiu E, Costantino J, Fisher B, Paik S, Wolmark N: Pathologic findings from the National Surgical Adjuvant Breast Projec (NSABP) eight-year update of Protocol B-17: intraductal carcinoma. Cancer 1999 86(3):429-38 Paik S, Bryant J, Park C, Fisher B, Tan-Chiu E, Hyams D, Fisher ER, Lippman ME, Wickerham DL, Wolmark N. erbB-2 and response to doxorubicin in patients with axillary lymph node-positive, hormone receptor negative breast cancer. J Natl Cancer Inst 90:1361-1370, 1998 Paik S, Bryant J, Tan-Chiu E, Yothers G, Park, C, Wickerham DL, and Wolmark N: HER2 and choice of adjuvant chemotherapy for invasive breast cancer: NSABP Protocol B-15. J Natl Cancer Inst 92:1991-8, 2000 Paik S, Liu ET: HER2 as a predictor of therapeutic response in breast cancer (review). Breast Disease 11: 91-102, 2000 Paik S, Park C: HER2 and choice of adjuvant chemotherapy in breast cancer (review). Seminars in Oncol in press, 2001 Paik S: Incorporating Genomics into the Cancer Clinical Trial Process. Seminars in Oncol, 28:305-309, 2001 Back to the contents 5. Links to Other Sites of Interest for Molecular Pathology of Breast and Colon Cancer Tissue Microarrayer Human Genome Browser Stanford Genomic Resources CGAP and NCBI GeneChip, cDNA Microarrays, and Protein Arrays Site Links Spectral Genomics (Commercial BAC Array for Array-CGH) KEGG (Pathway Maps) National Breast Cancer Center, Australia (Good Compilation of Breast Cancer Related Information) NCI Breast Cancer Think Tank Back to the contents 6. Important Information about Submitting Blocks to the NSABP We have noticed that NSABP sites are submitting blocks that are padded with bubble wrap. This is creating a problem because the bubble wrap has melted into the blocks destroying them. PLEASE DO NOT USE BUBBLE WRAP TO PAD YOUR SPECIMEN SHIPMENTS; USE PAPER INSTEAD! Please share this information with anyone within your institution who is responsible for shipping blocks. These blocks represent a valuable resource and we do not want to see them wasted. Back to the contents