Validation of Molecular Diagnostics to Predict Patient Outcomes Using Specimens from Multi-Site Cancer Trials (R01)

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This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), encourages the submission of Research Project Grant (R01) applications from institutions and organizations to validate the clinical utility of new molecular diagnostics for determining prognosis or predicting response to therapy or toxicity for cancer. The Cancer Diagnosis Program (CDP) and the Cancer Therapy Evaluation Program (CTEP) at the NCI are cooperatively sponsoring this FOA with the purpose to transition of candidate biomarkers from initial correlative observations into diagnostics that are suitable for use in clinical trials to assess the clinical validity of a marker. This program will support research projects to improve clinical decision-making in the care of cancer patients and as such will support studies that use tumor specimens linked to specific treatment and clinical outcome information. This FOA is not appropriate for molecular diagnostics discovery projects.

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