Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)

The National Cancer Institute (NCI) has announced a grant opportunity, titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer" that does not include clinical trials (UH2/UH3). This funding opportunity aims to support the testing and validation of biomarkers and assays in cancer detection, prognosis, monitoring, treatment response assessment, and prevention. Both analytical and clinical validations of these methods will be funded, particularly those that contribute to cancer treatment, control, or prevention.

Potential applicants should have assays that function effectively on human samples and hold significant potential for development into clinical assessments. As current cancer treatments often combine chemotherapy or radiation with immunotherapies, a focus on assays that can measure multiple markers, including immune markers, would be encouraged.

The grant will be divided into two phases. The UH2 phase requires the analytical validation of assays in the context of molecular, cellular and imaging markers, to be achieved within a period of two years. In the UH3 phase, the grant supports the clinical validation of these analytically validated assays for a period of up to three years. These tests will utilize well-annotated biospecimens from either retrospective or prospective clinical studies.

The grant can also be used to validate existing assays for use in a variety of cancer clinical trials, observational studies or population-oriented studies. Efforts to standardize clinical laboratory tests are also encouraged and could include investigations into the performance consistency and reproducibility of assays across several clinical laboratories.

This funding opportunity emphasizes a need for multi-disciplinary collaboration; thus, proposed projects should involve partnerships among scientific researchers, oncologists, statisticians, and clinical laboratory scientists.