Key Dates

Related Announcements

• November 10, 2021 - Request for Information: Seeking Input from Technology Developers on Liquid Biopsy Studies for Early Cancer Detection. See Notice NOT-CA-22-011.
• January 21, 2022 - Request for Information (RFI): Seeking Input from Multi-Cancer Early Detection Test Developers on Readiness for Participation in an NCI-Sponsored Clinical Utility Randomized Controlled Screening Trial. See Notice NOT-CA-22-033.
• March 29, 2023 - Notice of NCI Virtual Workshop to Engage Multi-Cancer Detection (MCD) Assay Developers. See Notice NOT-CA-23-055.
• May 3, 2024 - Request for Information (RFI): Seeking Input on Existing Study Populations with Multi-Cancer Detection (MCD) Test Results and Available Samples for Germline Testing. See Notice NOT-CA-24-046.
   

Issued by

National Cancer Institute (NCI)

Purpose

Through this Notice of Request for Information (RFI), the National Cancer Institute (NCI) is soliciting input from entities with study cohorts of individuals with germline genotyping and/or sequencing and cancer follow-up data. NCI is interested in assessing the feasibility of an NCI-sponsored ancillary study focused on MCD test performance among people at high genetic risk for cancer.

Background

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. Increased genetic risk for cancer can result from a single pathogenic variant (monogenic) or multiple genetic risk factors (polygenic). An existing challenge is how to screen for cancers from multiple organ systems among those at high genetic risk for cancer. Newly developed Multi-Cancer Detection (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. Test performance may differ in those at increased risk for cancer based on genetic factors because of differences in tumor biology and resulting circulating tumor biomarker prevalence, as well as due to differences in the prevalence and distribution of specific cancer types in these high-risk populations. 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 germline testing and cancer follow-up data. 
 

Information Requested

The purpose of this RFI is to assess the feasibility of conducting an ancillary research study to assess the performance of MCD tests among people at high genetic risk for cancer. Information on existing study cohorts of participants with germline testing complete (genotyping and/or sequencing) and cancer follow-up data is needed. The participants would not need to have had MCD testing previously performed but would need to already be consented for research use of any banked samples that may be available for MCD testing. 
 

The NCI seeks information on the topics listed below. If any of the requested information is available on a website or in a publication(s), please provide appropriate links/citations.

• Interest in participating in an NCI-led ancillary study to evaluate MCD test performance among people at high genetic risk for cancer.
• Description of the study population(s) available, including study design and inclusion/exclusion criteria.
• Description of germline testing, including assay(s) used, and availability of data from germline testing.
• Total number of cancer cases in the study population.
• Total number of individuals without cancer in the study population.
• Number of individuals with a hereditary cancer syndrome (e.g. Lynch syndrome, HBOC) and the specific hereditary cancer syndromes represented in the study population, if known.
• Number of individuals without a hereditary cancer syndrome in the study population, if known.
• Availability, if any, of banked blood specimens collected via Cell-Free DNA Collection Tubes.
• Availability, if any, of banked plasma specimens processed and frozen within 1 hour of collection.
   

How to Submit a Response

Responses to this RFI must be submitted electronically to: NCI_DCCPS_MCD@nih.gov

Responses will be accepted through 06/17/2024. Every respondent will receive an automated e-mail confirmation acknowledging receipt of a successfully submitted response. After receiving your response, NCI may follow up with you to request additional information. Responses are entirely voluntary. No proprietary, classified, confidential, or sensitive information should be included in your response. Please include the Notice number (NOT-CA-24-051) in the subject line. All individual responses will remain confidential. The NIH will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), and/or the NCI to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this RFI or from the Government’s use of such information.

NIH looks forward to your input, and we hope that you will share this RFI document with your colleagues.

Inquiries

Please direct all inquiries to:

Andrea Burnett-Hartman, PhD, MPH
National Cancer Institute (NCI)
Telephone: 301-357-3411
Email: andrea.burnett-hartman@nih.gov