Key Dates

Related Announcements

PAR-20-313 - Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)

PAR-20-314 - Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)

NOT-CA-21-095 - Notice of Change to Research Objectives and Eligibility of Foreign Components for PAR-20-313 - Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)

Issued by

National Cancer Institute (NCI)

Purpose

The purpose of this Notice is to clarify the research objectives and to revise language regarding the eligibility of foreign components in Funding Opportunity Announcement (FOA), PAR-20-314, Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed).

The following sections of PAR-20-314 have been modified:

Currently Reads:

Part 2. Section I. Funding Opportunity Description

Research objectives

Applications in response to this FOA must propose to optimize an existing assay(s) using human specimens in a clinical laboratory into assays that can be used in a clinical trial/study for the treatment, prevention or control of cancer. However, 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.

The primary elements for achieving the research objectives are as follows:

• Existing assay: an assay that has been reduced to practice in human tissues. The assay may be from discovery research or based on the scientific investigator's interests.
• Clinical laboratory: a laboratory that provides assay results that either assist in medical decision-making or test postulates or mechanisms of action of clinical, prevention or cancer control treatments or interventions. Assays that support medical decision-making need to be performed in CLIA-certified laboratories. Assays to test postulates or mechanisms should conform to GLP or ISO 17025 standards, in order to assure that the data generated by the assays are of sufficient quality as to be useful in clinical trials and justify sample collection.
• Markers/Biomarkers: molecular/cellular/imaging markers that are associated with a clinical endpoint in a pre-defined clinical context or situation that yields usable information about diagnosis, prognosis, or response to clinical intervention for treatment, prevention, or control of cancer.

Modified to Read (changes shown in bold italics):

Part 2. Section I. Funding Opportunity Description

Research objectives

Applications in response to this FOA must propose to optimize an existing assay(s) using human specimens in a clinical laboratory into assays that can be used in a clinical trial/study for the treatment, prevention or control of cancer. However, 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. In the context of these FOAs “imaging” refers to in vitro imaging modalities such as microscopy but not clinical radiology.

The primary elements for achieving the research objectives are as follows:

• Existing assay: an assay that has been reduced to practice in human tissues. The assay may be from discovery research or based on the scientific investigator's interests.
• Clinical laboratory: a laboratory that provides assay results that either assist in medical decision-making or test postulates or mechanisms of action of clinical, prevention or cancer control treatments or interventions. Assays that support medical decision-making need to be performed in CLIA-certified laboratories. Assays to test postulates or mechanisms should conform to GLP or ISO 17025 standards, in order to assure that the data generated by the assays are of sufficient quality as to be useful in clinical trials and justify sample collection.
• Markers/Biomarkers: molecular/cellular/imaging markers that are associated with a clinical endpoint in a pre-defined clinical context or situation that yields usable information about diagnosis, prognosis, or response to clinical intervention for treatment, prevention, or control of cancer. NOTE: In the context of these FOAs "imaging" refers to in vitro imaging modalities (e.g. microscopy) not clinical radiology (e.g. PET or MRI).

Currently Reads:

Part 2. Section III. Eligibility Information

1. Eligible Applicants

Foreign Institutions

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 NIHGrants Policy Statement, are not allowed.

Modified to Read (changes shown in bold italics):

Part 2. Section III. Eligibility Information

1. Eligible Applicants

Foreign Institutions

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 allowed.

All other aspects of this FOA remains the same.

Inquiries

Please direct all inquiries to:

For inquiries related to cancer diagnosis, prognosis, treatment response, and monitoring biomarkers and assays, please contact:

Sumana Dey, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5748
Email: sumana.dey@nih.gov

Tracy G. Lively, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5944
Email: livelyt@mail.nih.gov

For inquiries related to companion diagnostics and pharmacodynamic and safety markers for treatment trials, please contact:

Minkyung (Min) Song, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276- 6139
Email: songm@mail.nih.gov

For inquiries related to assays involving screening and early detection, please contact:
Lynn Sorbara, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7135
Email: lynns@mail.nih.gov

For inquiries related to cancer prevention markers and assays, please contact:
Asad Umar, DVM, Ph.D.
National Cancer Institute
Telephone: 240-276-7070
Email: umara@mail.nih.gov

For inquiries related to assays involving cancer epidemiology and population science, please contact:
Rao Divi, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6913
Email: divir@mail.nih.gov

Mukesh Verma, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276- 6889
Email: vermam@mail.nih.gov