Request for Information (RFI): Seeking Input on Existing Study Populations with Multi-Cancer Detection (MCD) Test Results and Available Samples for Germline Testing
Notice Number:
NOT-CA-24-046

Key Dates

Release Date:

May 3, 2024

Response Date:
June 10, 2024

Related Announcements

  • NOT-CA-24-051 - Request for Information (RFI): Seeking Input on Existing Study Populations with Germline Results and Samples Available for Multi-Cancer Detection (MCD) Assay Testing
  • March 29, 2023 -   Notice of NCI Virtual Workshop to Engage Multi-Cancer Detection (MCD) Assay Developers. See NOT-CA-23-055
  • November 10, 2021 -   Request for Information: Seeking Input from Cohort and Biorepository Researchers on Liquid Biopsy Studies for Early Cancer Detection. See NOT-CA-22-010
  • November 10, 2021 -   Request for Information: Seeking Input from Technology Developers on Liquid Biopsy Studies for Early Cancer Detection. See 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 NOT-CA-22-033
     

Issued by

National Cancer Institute (NCI)

Purpose

Through this Notice of Request for Information (RFI), the National Cancer Institute (NCI) is soliciting 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.


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 MCD 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. Existing samples suitable for germline sequencing would need to be available from participants who were part of existing cancer case-control, cancer case series, or longitudinal studies and had MCD test results. The participant would not need to have had germline testing performed but would need to already be consented for germline testing. 


The NCI seeks information on as many of the topics listed below for which information is available. 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 samples available for germline sequencing among individuals that have already been tested using an MCD test and description of the MCD test used.
  • Description of the study population(s) available, including study design and inclusion/exclusion criteria.
  • Total number of cancer cases in the study population.
  • Total number of individuals without cancer in the study population.

  •  How to Submit a Response


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


    Responses will be accepted through 06/10/2024. 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-24-046) 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