The patient tissue and blood sampling strategies are identical for all three Research Projects to allow the collection of variables from orthogonal measurements on the same samples. The Clinical Sample Core (CSC) will serve as the interface between the clinical cancer centers and the Research Proj ects. In particular, the CSC will be responsible for collecting, processing, and tracking blood samples and tissue samples and distributing them to the Research Projects in the appropriate format requested by Investigators. The CSC personnel are trained and will be directly supervised by the senior co-Lead investigator Dr. Kelly Bethel, who will also provide the communications interface to the medical oncology and research project investigators. The CSC is also responsible for all human subject regulations. For patient cohort 1, the CSC will deliver tissue samples from various sites of the primary tumor and regional metastases, as well as circulating tumor cells from blood samples in both patients with lung cancer and colon cancer. Fo r patient cohort 2, the CSC will provide CTCs isolated from the blood of 150 newly diagnosed patients with colon cancer and 150 newly diagnosed patients with lung cancer. For each of the tumor types, 50 of the patients will have eariy stage cancers at the time of diagnosis (l-ll); 50 patients will have midstage (III) cancers at the time of diagnosis, and 50 will be patients presenting with metastatic stage disease.
The CSC is composed of medical oncology, pathology, and surgery experts across three cancer centers. This will guarantee a high quality ofthe clinical program and sample preparation for the greatest likelihood of success in the proposed three Research Proj ects. The team also has the expertise and experience to deli ver human samples to each Invesgator in the form factor necessary to make their measurements.
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