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139th National Cancer Advisory Board

robust data emerge from this project. She pointed out that the Genome Sequencing Centers and the Genome Characterization Centers can be considered two sides of a coin in that they are the group that will work on such areas as copy number changes, expression profiling, and resequencing. Data management, bioinformatics, and computational analysis will constitute the fourth component of the TCGA network. Underlying everything is technology development that will be funded by both the NHGRI and NCI. Dr. Barker observed that the patient, patient advocacy, research, and medical communities will be engaged in various aspects of the project.

Because it is central to TCGA Pilot success, the Biospecimen Core Resource will: (1) receive the tissue samples, verify all of the biologic and clinical data, and perform the pathologic QC; (2) perform central processing of specimens to provide uniform biomolecules for distribution to both Genome Characterization and Sequencing Centers; (3) track and quality assure all specimen-related operations, including ensuring that specimens are appropriately consented; (4) provide “standard” samples for technology platform comparisons; (5) develop (with the Office of Biorepositories and Biospecimen Research) and monitor the standard operating procedures for prospective specimen collection; and (6) serve as a member of the TCGA’s Steering Committee, which will be composed of the principal investigators from the Cancer Genome Sequencing Centers and the Genome Characterization Centers.

Dr. Barker described the complications associated with the selection of categories of biospecimen collections to initiate the TCGA Pilot. In the end, it was decided one tumor type will be selected from qualifying biorepositories in three categories: (1) a tumor representing a major public health problem, because TCGA is about creating new interventions for patients; (2) a tumor type that demonstrates a high degree of homogeneity; and (3) a collection that derives from a completed clinical trial where patients were treated in the same manner. Next, Dr. Barker described the robust evaluation process for selecting the biorepositories to be included in TCGA, which began with the issuance of an RFI and notification to Cancer Centers. Rigorous primary and secondary criteria will be applied in the evaluation process. She announced that three tumors have been selected for the specified categories, and she commended the altruism displayed by the institutions that will be providing the specimens for TCGA.

Qualifications sought in the Cancer Genome Characterization Centers were: (1) technology platforms for high throughput genome characterization; (2) the capacity and willingness to work on improving and developing existing technologies; and (3) concurrence with the requirement for real-time data release into a public database. Dr. Barker noted that the cooperative agreement mechanism (U24) will be used to promote collaboration and cooperation and provide for the governance structure that is represented by the TCGA Steering Committee. Peer review of the applications has been completed and awards will be announced in October. Similarly, U24 applications for NHGRI’s Genome Sequencing Centers have been reviewed, and the awards will be announced in December. Members were reminded that the NHGRI is dedicating $50 M from its sequencing budget for this project. NCI’s caBIGTM will provide a bioinformatics platform for TCGA. All molecular and clinical data from both the Genome Characterization and Sequencing Centers will be deposited in the public TCGA database that is under development through caBIGTM. The data will be made available through caBIGTM and through the National Library of Medicine’s National Center for Biotechnology Information (NCBI).

In the course of organizing this project, according to Dr. Barker, it became apparent the TCGA and other large-scale medical genomics efforts must address several ethical, legal, and policy issues (ELPIs). These include: the level of detail in the informed consent; who should have access to data; how to leverage and capitalize on the potential for progress and ensure privacy protection; and whether new forums of patients, clinicians, researchers, and ethicists will be needed to discuss these issues and inform policy. Dr. Barker noted that the NCAB has considered these ELPI and informed consent issues in the past and that the NIH is taking a lead in the effort to develop policy in this area because of TCGA and the


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