The National Cancer Institute (NCI) is offering this grant to support the validation of molecular, cellular, and imaging markers, alongside their corresponding assays, for various cancer applications. This includes detection, diagnosis, prognosis, monitoring, and predicting treatment response or resistance. The grant also covers markers for cancer prevention, control, pharmacodynamics, and toxicity. This funding opportunity is for investigator-initiated research, encompassing both analytical (UH2 phase) and clinical (UH3 phase) validation of assays that work on human samples. It encourages validating existing assays for use in clinical, observational, or population studies, and supports efforts to harmonize clinical laboratory tests. Multi-disciplinary collaboration is essential for proposed projects.
Opportunity ID: 329418
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-20-313 |
| Funding Opportunity Title: | Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Education Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.394 — Cancer Detection and Diagnosis Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Oct 13, 2020 |
| Last Updated Date: | Oct 13, 2020 |
| Original Closing Date for Applications: | Oct 10, 2023 |
| Current Closing Date for Applications: | Oct 10, 2023 |
| Archive Date: | Nov 15, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) State governments Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments For profit organizations other than small businesses County governments Independent school districts Public housing authorities/Indian housing authorities Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) invites applications to support the validation of molecular/cellular/imaging markers (referred to as “markers” or “biomarkers”) and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This FOA will support investigator-initiated research for both analytical, and clinical validation of assays to be used in cancer treatment, control, or prevention trials supported by the NCI. This FOA will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants should have assays that work on human samples and whose importance is well justified for development into clinical assays. As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance thedurability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. The UH2 phase of this FOA supports analytical validation of assays for these molecular/cellular/imaging markers, which must be achieved within 2 years before assays may undergo clinical validation. The UH3 phase of this FOA supports clinical validation of analytically validated assays for up to 3 years using well-annotated biospecimens from retrospective or prospective clinical trials or studies. This FOA may be used to validate existing assays for use in other cancer clinical trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this FOA will require multi-disciplinary collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientist. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-20-313.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 329418 Full Announcement-PAR-20-313 -> PAR-20-313-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-F | Use for due dates on or before January 24, 2022 | PKG00263770 | Jan 18, 2021 | Jan 24, 2022 | View | |
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00270561 | Nov 22, 2021 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278423 | Nov 15, 2022 | Oct 10, 2023 | View |
Package 1
Mandatory forms
329418 RR_SF424_2_0-2.0.pdf
329418 PHS398_CoverPageSupplement_5_0-5.0.pdf
329418 RR_OtherProjectInfo_1_4-1.4.pdf
329418 PerformanceSite_2_0-2.0.pdf
329418 RR_KeyPersonExpanded_2_0-2.0.pdf
329418 RR_Budget_1_4-1.4.pdf
329418 PHS398_ResearchPlan_4_0-4.0.pdf
329418 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
329418 RR_SubawardBudget30_1_4-1.4.pdf
329418 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
329418 RR_SF424_5_0-5.0.pdf
329418 PHS398_CoverPageSupplement_5_0-5.0.pdf
329418 RR_OtherProjectInfo_1_4-1.4.pdf
329418 PerformanceSite_4_0-4.0.pdf
329418 RR_KeyPersonExpanded_4_0-4.0.pdf
329418 RR_Budget_3_0-3.0.pdf
329418 PHS398_ResearchPlan_4_0-4.0.pdf
329418 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
329418 RR_SubawardBudget30_3_0-3.0.pdf
329418 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
329418 RR_SF424_5_0-5.0.pdf
329418 PHS398_CoverPageSupplement_5_0-5.0.pdf
329418 RR_OtherProjectInfo_1_4-1.4.pdf
329418 PerformanceSite_4_0-4.0.pdf
329418 RR_KeyPersonExpanded_4_0-4.0.pdf
329418 RR_Budget_3_0-3.0.pdf
329418 PHS398_ResearchPlan_5_0-5.0.pdf
329418 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
329418 RR_SubawardBudget30_3_0-3.0.pdf
329418 PHS_AssignmentRequestForm_3_0-3.0.pdf
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