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NCI Seeks Input on Existing Study Populations with Multi-Cancer Detection Test Results and Available Samples for Germline Testing

The National Cancer Institute (NCI) published a Request for Information (RFI) in the NIH Guide for Grants and Contracts seeking input from those with cancer case-control, cancer case series, or longitudinal studies of Multi-Cancer Detection (MCD) liquid biopsy tests about the feasibility of an NCI-sponsored ancillary study focused on MCD performance among people at high genetic risk for cancer.

Individuals with a higher genetic risk for cancer frequently face elevated risk for various types of cancer, encompassing cancer types with recommended screening tests or procedures and those without. An existing challenge is how to screen for cancers from multiple organ systems among those at high genetic risk for cancer. Newly developed MCD liquid biopsy tests have the potential to detect multiple types of cancer from a single blood draw, including cancers for which there are currently no recommended screening modalities available. A single blood test capable of identifying the multiple cancers in those with genetic predisposition to cancer offers a promising solution but currently lacks the evidence that these tests are effective in any population, including those at high genetic risk for cancer.

Although reports of MCD test performance, including sensitivity, specificity, positive predictive value, and negative predictive value, are available for average-risk populations, there is currently limited information on MCD test performance among individuals at high genetic risk for cancer. Additional research is needed to determine the performance of MCD tests among those at high genetic risk for cancer, and the generation of evidence may be possible by use of existing study populations with prior MCD testing and cancer follow-up data.

NCI seeks information on the topics listed below.

1. Interest in participating in an NCI-led ancillary study to evaluate MCD test performance among people at high genetic risk for cancer.
2. Description of the samples available for germline sequencing among individuals that have already been tested using an MCD test and description of the MCD test used.
3. Description of the study population(s) available, including study design and inclusion/exclusion criteria.
4. Total number of cancer cases in the study population.
5. Total number of individuals without cancer in the study population.

Access the Request for Information: https://grants.nih.gov/grants/guide/notice-files/NOT-CA-24-046.html.

Comments can be submitted electronically through June 10, 2024, to NCI_DCCPS_MCD@nih.gov. Please include the Request for Information Notice number (NOT-CA-24-046) in the subject line of your email. All individual responses will remain confidential.