Background/Aims: KRAS testing is a pharmacogenomic test to help decide how to treat patients with metastatic colorectal cancer (mCRC). The CERGEN (Comparative Effectiveness Research in Genomics & Personalized Medicine for Colorectal Cancer) project, a collaboration among eight institutions of the NCI-funded Cancer Research Network (CRN) and four academic partners, utilized KRAS test results to evaluate overall survival in mCRC patients. As a part of this project, we needed to retrospectively test all patients that had not had the testing done as part of their clinical care. This project is a large, multisite CRN project utilizing archived tumor tissue
Methods: For cases that had not been previously tested for KRAS mutation status at the seven data collection sites, we tested archived pathology specimens from the primary tumor. Testing was planned to be performed at one central laboratory that was not affiliated with any of the institutions. Each site needed to identify study patients that had not been KRAS tested, retrieve blocks that could be utilized for research, section blocks per laboratory requirements, and return testing results to the lead site
Results: All sites required varying degrees of approvals, paperwork, and sample processing. Despite many challenges, we successfully performed KRAS testing on tumor tissue from over 400 blocks. This poster will present the issues and challenges encountered at each of the seven sites in performing testing on tumor blocks, including: varying IRB requirements at each site; challenges around IRB ceding; site-specific biospecimen committees; timing around slides sent to the laboratory; staffing challenges in pathology; and varying material transfer and data sharing agreements. Additionally, the pathology department at one site required in-house testing only. We will also share our successes including: pilot testing the process before implementation; shipping blocks to another site for sectioning when there were pathology staffing shortages; working to standardize IRB applications; and working with the laboratory to ensure quality control in all of the samples.
Conclusions: We were successfully able to standardize tumor block testing for research across seven HMORN sites. We hope that our “lessons learned” are helpful for other HMORN projects that wish to use archived tissue.