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SEER-LINKED VIRTUAL TISSUE REPOSITORY Rosemary D. Cress, DrPH December 7, 2015 Biospecimens and cancer research It is becoming increasingly obvious that categorizing cancers merely by anatomic site is inadequate to understanding the heterogeneity of risk factors, response to treatment and prognosis. For example, subtypes of breast cancer based on hormone receptor status have been shown to vary in prognosis and require different target treatments. Gene expression profiling has been shown to identify breast cancer patients at higher risk of recurrence, sparing low risk women the morbidity of chemotherapy. Biospecimens and cancer research (2) This increases the importance of including biospecimens in cancer research. However, collecting biospecimens is expensive and can only be done on a small number of research subjects. Institutional biorepositories are valuable resources but have limitations for population based research. The SEER program The Surveillance, Epidemiology and End Results (SEER) program of the National Cancer Institute has collected population based data on cancer from across the US since 1972. Data collected include demographics (age, race), tumor information (site, histology), stage at diagnosis, first course of treatment, and vital status, which is updated annually. SEER Cancer Registry Regions -Initiated in 1973 -In 2001: all of CA was included in expansion -SEER represents 28% of US population http://www.seer.cancer.gov/ -California makes up 47% of the SEER population SEER and biospecimens SEER has had a long interest in enhancing their data with biospecimens, and making biospecimens annotated with registry data available to cancer researchers. In 2001, SEER funded three Residual Tissue Repositories (RTRs) in Iowa, Hawaii and Los Angeles. SEER and biospecimens (2) These registries collected formalin-fixed paraffin-embedded (FFPE) tissues from hospital laboratories as they were discarded, and linked them to SEER registry data in those areas. The RTRs supported an enormous amount of research but proved very expensive to maintain. SEER Virtual Tissue Repository (VTR) Experience and best practices indicate that the NCI SEER program can support cancer research by creating a SEER-linked Virtual Tissue Repository (VTR). In this model, SEER registries would serve as an “honest broker”, requesting biospecimens from reporting hospitals, annotating them with patient and tumor data, and providing deidentified specimens to researchers. SEER VTR A SEER VTR, with its population representativeness and large sampling frame, would be a unique resource for assembling robust collections of annotated biospecimens, even for rare tumors and outcomes. In 2015, SEER issued a request for proposals to participate in a VTR pilot study SEER VTR (2) SEER registries selected to participate include Hawaii, Iowa, Connecticut, Louisiana, Kentucky, Utah, and Greater California (the registry that covers all of California except Los Angeles and the Greater SF Bay Area). SEER VTR (3) The objectives of this study are: To assess the ability of SEER Contractor Registries to serve as a resource for biospecimen research. To locate patients with biospecimens in pathology laboratories and determine the requirements to retrieve those biospecimens. To provide custom annotation of specified data items. To capture costs for identifying each available biospecimen and performing custom annotation of each biospecimen. SEER VTR (4) SEER annotation includes information routinely collected by SEER registries including demographic and clinical characteristics such as tumor histology, treatment, and outcomes. Annotation can also include custom data, abstracted from medical records, such as detailed chemotherapy, time to recurrence, and body mass index. Cancer Registry of Greater California The Cancer Registry of Greater California (CRGC) became part of the SEER program in 2001 CRGC collects information from a broad geographic area with a population of nearly 20 million people residing in 48 of the 58 counties of California. The CRGC population is very diverse by race/ethnicity, urban/rural residence, and socioeconomic status. Over 80,000 new invasive cancer cases are diagnosed and processed by CRGC staff each year. CRGC is the largest SEER registry participating in VTR. SEER VTR (5) The study will focus on the feasibility of collecting specimens from selected breast and pancreas cancer patients. Breast “cases”: those that survived less than 2 years Breast “controls”: survived at least 5 years Pancreas “cases”: those that survived at least 5 years Pancreas “controls”: survived less than 2 years SEER VTR methods Study staff are in the process of identifying 200 eligible patients from the CRGC database Staff are querying our registry data management system to identify hospitals where sampled patients received definitive surgery, as well as pathology text information, pathology report number, and/or medical record number. Electronic and paper pathology reports will be collected SEER VTR methods (2) CRGC staff will contact hospital and free standing pathology laboratories that according to our records have relevant specimens They will conduct a survey to assess the laboratory’s willingness to provide an H&E slide along with 10 unstained sections for analysis, or a tumor block to be processed by a pathology laboratory in our area. SEER VTR methods (3) For hospitals willing to provide specimens, staff will collect information on requirements and costs. A standardized survey to collect information about the laboratory’s willingness to share tissues, ethical and privacy requirements to share de-identified and barcoded specimens, and terms under which materials are available is currently being finalized in conjunction with SEER and other PIs. SEER VTR methods (3) We will request a pathology review in pathology laboratories willing to share tissues of up to 10 randomly selected pancreatic or breast cancer control subjects to assess specimen quality. For hospitals unwilling or unable to provide specimens, reasons for this also will be collected. SEER VTR methods (4) In addition to routine registry information, SEER has requested that registries collect additional information from medical records, including detailed information about treatment and cancer recurrence. SEER VTR – current status This study is still in its initial stages SEER has provided lists of “cases” but is still developing lists of “control” subjects We have applied for institutional (Public Health Institute) IRB approval for the study. Dr. Regina Gandour-Edwards, director of the UCD Cancer Center Biorepository, is serving as a consultant to the CRGC. Conclusions Although there are major challenges to overcome, this study promises to greatly advance research requiring population based biospecimens. If successful, the CRGC hopes to develop the infrastructure to conduct much more of this type of research in the future. Questions?