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139th National Cancer Advisory Board

other NIH projects dealing with these issues. As an indication of the difficulty of arriving at a universally acceptable informed consent, Dr. Barker noted that a draft informed consent for TCGA use that was 9 months in the making was critiqued and dismissed in a recent workshop.

Looking ahead, the expectations are that the TCGA Pilot will succeed in completing the genomic analysis of three tumors, and will make it possible to identify some alterations in genes that are associated with cancer and differentiate tumor subtypes based on genomic alterations. The ultimate goal is the establishment of a database with all data from the TCGA Pilot that scientists can access for followup experiments. It is expected that this will empower and enable a whole new era of science for cancer that will create hypothesis testing similar to that seen shortly after the genome itself was sequenced. Expectations for TCGA in the long term include the ability to identify those somatic changes in cancer genomes that could establish the molecular basis for each cancer and establish molecular oncology as the approach to personalized medicine. A new era of oncology could be envisioned—one that is preemptive and preventive as well as targeted in terms of new therapies, adds to knowledge in the biomarker area, and improves the ability to stratify patients for clinical trials.

Dr. Barker directed those interested in knowing more about TCGA or receiving automated updates to the Web site http://cancergenome.nih.gov. She acknowledged and thanked the many people responsible for bringing TCGA through the 4 years of planning to a place where the project is now in the hands of the extramural world that is going to execute it.

Questions and Answers

Dr. Peter Kirchner, Senior Scientist, Office of Biological and Environmental Research, Department of Energy, asked whether TCGA would be sampling early metastases sequentially over time to see if there are genomic subtype changes following therapy or just as an evolution of time. Dr. Barker replied that the intent was to choose tumors that would lessen that concern. The tumors chosen for this project in the three categories are primary tumors, not metastases. However, biologists might be expected to look for those kinds of indicators in the data over time. Dr. Everson suggested, based on experience in his institution’s network, that TCGA should ensure that there is a dedicated resource at the site collecting the tissue. In response, Drs. Barker and Carolyn Compton, Director, Office of Biorepositories and Biospecimen Research, OD, reviewed the rigorous criteria for locating specimens to ensure that those identified for TCGA are of very high quality and will fulfill the technological needs of the project in regard to providing meaningful biologic and clinical data. Dr. Coffey asked whether alternate splicing, where one gene can make hundreds of different proteins, is covered in TCGA; whether any karyotyping would be done; and whether TCGA investigators would be looking at the RNA pattern. Dr. Barker replied in the affirmative to the first and last query and noted that she did not think any of the TCGA centers would be doing karyotyping.

Dr. Barker stated that TCGA has benefited from the experience gained in the mini-genome program organized by the Multiple Myeloma Research Consortium shortly after planning for the NCI project began. Ms. Giusti recounted lessons learned: (1) it was necessary to station coordinators at each of the 11 sites submitting tissue to ensure that the standard operating procedures developed for the project were followed and tissue was collected only from untreated patients; (2) it was beneficial for the 11 sites and for the overall project to track metrics and distribute a monthly report as to amount of tissue collected and sent, number of patients accrued, and speed of the IRB review at each site; (3) it was deemed valuable to hire a contract research organization to conduct a review of the data that are being accumulated; (4) it may be necessary to expand the collection process to Europe to access enough tissue from untreated patients; (5) it was necessary to adjust quality standards over time when an old standard was found to be

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