The National Cancer Institute is actively working with researchers across the Institute and at other federal agencies to investigate all aspects of multi-cancer detection tests. These teams address different, but related aspects of the science:
- Biology and Technology Team
- Utilization of Cohorts and Prospective Study Designs Team
- MCD Trial Team
Biology and Technology Team
This team is addressing questions central to the biology of tumor biomarkers and how technologies can successfully measure markers.
Key questions include:
- Why do some organs shed more DNA than others?
- Why do patients with the same cancer type shed DNA differently: some more and others less (intra-disease heterogeneity, tumor microenvironment)?
- At what point in time (tumor progression) does the shedding begins and how is it regulated?
- How does EMT (epithelial to mesenchymal transition) or the tumor’s microenvironment influence DNA shedding?
This team is planning to hold a workshop on Biology of Tumor Cell Shedding which could potentially lead to the develop a funding opportunity to address the relevant biological issues. The team actively collaborates with the Liquid Biopsy Consortium, who will be reissuing a Request for Applications later this year.
This team issued a Request for Information to identify others interested in these areas:
| Number | Notice Title | Dates |
|---|---|---|
| NOT-CA-22-011 | Request for Information: Seeking Input from Technology Developers on Liquid Biopsy Studies for Early Cancer Detection | Now closed: 01/15/2022 |
Other related Funding Opportunity Announcements:
| Number | Funding Opportunity Title | Dates |
|---|---|---|
| PAR-20-313 | Assay Validation of High-Quality Markers for Clinical Studies in Cancer (UH2/UH3) | Open through 10/11/2023 |
| PAR-20-314 | Assay Validation of High-Quality Markers for Clinical Studies in Cancer (UH3) | Open through 10/11/2023 |
| PA-21-259 | Small Business Innovation Research Grant Applications (R43/R44) | Now closed: 04/06/2022 |
| PA-21-262 | Small Business Technology Transfer Grant Applications (R41/R42) | Now closed: 04/06/2022 |
| RFA-CA-17-029 | Precompetitive Collaboration on Liquid Biopsy for Early Cancer Assessment (U01) | Now closed: 01/23/2018 Due for renewal in 2022 |
Utilization of Cohorts and Prospective Studies Team
The Cohorts and Prospective Studies Team is looking to identify appropriate cohorts, biorepositories, or other studies which may be leveraged for studies to examine pre-diagnostic performance of MCD tests. This includes utilizing existing samples (retrospective) or adding new samples (prospective) to ongoing studies. They also plan to facilitate collaborations among technology developers and cohort and biorepository researchers.
This team is developing a workshop on Strategic Partnerships and Technology Development for Liquid Biopsy to encourage partnerships between technology developers and biorepository researchers to facilitate studies with the appropriate samples and optimal design
The team has published one notice:
| Number | Notice Title | Response Date |
|---|---|---|
| NOT-CA-22-010 | Request for Information: Seeking Input from Cohort and Biorepository Researchers on Liquid Biopsy Studies for Early Cancer Detection | Now closed: 01/15/2022 |
And is planning to release a second one soon on Utilization of Cohorts and Prospective Study Designs for M.C.D. Assay Validation for Early Detection of Cancers.
Plans are being developed to partner with existing cohort studies to demonstrate the potential of liquid biopsy technologies for early detection and to inform understanding of the timing of detection of liquid biopsy biomarker signals prior to cancer diagnosis.
MCD Trial Team
In October 2021, the MCD trial team had a Study Design Workshop where NCI staff presented the basic structure for a trial and several specific questions for which they wanted input. Participants included 30 external investigators, including academic biomarker researchers, primary care physicians with cancer screening expertise, and clinical trials experts.
From this workshop came the agreement that NCI needs to evaluate MCD assays for their clinical benefit, that there is a need to rigorously capture and understand the harms from using the MCD assays for cancer screening and strong support to conduct a vanguard study to asses feasibility of randomization and the clinical workflow for the diagnostic pathway.
In January 2022, this team sent out a Request for Information, seeking input from developers of M.C.D. assays on their readiness (and willingness) to participate in an NCI-sponsored clinical utility screening trial:
| Number | Notice Title | Response Date |
|---|---|---|
| NOT-CA-22-033 | Request for Information (RFI): Seeking Input from Multi-Cancer Detection Test Developers on Readiness for Participation in an NCI-Sponsored Clinical Utility Randomized Controlled Screening Trial | Now closed: 03/02/2022 |
NCI received 17 responses from developers of assays, companies, and academic centers.
The team has been working with the Alliance for Clinical Trials to create a biobank for evaluating MCD tests. The study, called “Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection” will begin collecting samples this year.
Ongoing activities of the MCD Trial Team have spread into four working groups:
- Assay Working Group is meeting with respondents to the RFI and other sponsors of assays to consider readiness and willingness to incorporate assays into NCI studies;
- Diagnostic Pathway Working Group is evaluating how best to develop diagnostic pathways for study protocols;
- Ethics and Equity Working Group is developing mechanisms for capturing participant understanding of M.C.D. technologies and cancer screening in general; and
- Trial Design Working Group continues with plans for a pilot study.