Current Funding Opportunities
Visit this page often to find new biospecimen-related funding opportunities from the NCI Biorepositories and Biospecimen Research Branch and other NIH Research Programs.
Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trials Not Allowed)
PAR-22-049
Posted date: October 22, 2021
Open date (Earliest submission date): December 11, 2021
Application Receipt Dates: September 13, 2022; January 11, 2023; June 07, 2023; September 13, 2023; January 11, 2024; June 07, 2024; September 13, 2024 by 5:00 PM local time of applicant organization.
This Notice of Funding Opportunity (NOFO) will support extramural research to investigate and mitigate challenges facing clinical assay development and subsequent analytical validation due to preanalytical variability in tumor tissue biopsies and blood biospecimens utilized as “liquid biopsies.” Extramural research funded under this FOA may include investigations of preanalytical variability associated with the procurement and study of small biopsies (core biopsies, small excision samples), pleural aspirates, and blood utilized for liquid biopsies. Investigator-designed experiments will explore how different biospecimen preanalytical conditions affect emerging and clinically relevant biomarkers quantified by a variety of testing platforms. The results from this research program will improve the understanding of how analytical quantification of clinically relevant biomarkers is affected by variation in biospecimen collection, processing, and storage procedures. The overall goal is to expedite biomarker clinical assay development through evidence-based standardization of biopsy handling practices.
https://grants.nih.gov/grants/guide/pa-files/PAR-22-049.html
Since the inception of this funding opportunity 21 awards have been funded. Below is a table of the grants funded to date. The information is periodically updated and may not reflect the most up-to-date status. Additional information can be found on the NIH RePORTER website.
Grants Funded to Date
| Grant number | Title | Grantee, Institution | Award Period |
|---|---|---|---|
| U01CA215547-01 | Integrating biospecimen science into the development of RNA- based clinical assays for patients with metastatic breast cancer | William F. Symmans, MD Anderson Cancer Center |
04/2017 - 03/2022 (Award Completed) |
| U01CA229345-01A1 | Mitigation of preanalytical factors influencing brain tumor protein phosphorylation | Joanna Phillips, University of California San Francisco |
04/2019 - 03/2024 (Award Completed) |
| U01CA243078-01A1 | Pre-analytical factors affecting ctDNA analysis in early and locally advanced breast cancer | Muhammed Murtaza, University of Wisconsin-Madison |
09/2019 - 08/2024 (Awarded) |
| U01CA246503-01A1 | Influence of pre-analytical factors in glioblastoma MGMT promoter methylation biomarker assay | Karol Bomsztyk, University of Washington |
03/2020 - 02/2025 (Awarded) |
| U01CA253190-01 | Optimizing pre-analytic sample handling for high throughput TCR sequencing in cutaneous T cell lymphoma | Rachel Clark, Brigham Women’s Hospital |
07/2020 - 06/2025 (Awarded) |
| U01CA253166-01 | Liquid biopsy of the lung to profile lung cancer | Viswam Siva Nair, Fred Hutchinson Cancer Center |
07/2020 - 06/2025 (Awarded) |
| U01CA253217-01 | Evaluation of the Effect of Patient-Context Factors and Sample Acquisition on the Quality and Analytical Performance of cfDNA Profiling Assays in Prostate Cancer Patients | Maria Arcila, Memorial Sloan Kettering Cancer Center |
09/2020 - 08/2025 (Awarded) |
| U01CA263986-01A1 | Evaluation of Patient Factors and Sample Pre-Analytics on Predictive Multiplex Immunohistochemical Assays in Immuno-Oncology Patients | Michael Roehrl, Beth Israel Deaconess Medical Center, Harvard Medical School |
07/2021 - 06/2026 (Awarded) |
| U01CA260369-01 | Optimization of Urinary DNA Deep Sequencing Tests to Enhance Clinical Staging of Bladder Cancer Patients | Phillip Abbosh, Fox Chase Cancer Center |
08/2021 - 07/2026 (Awarded) |
| U01CA263988-01 | Robust assays to define telomere maintenance mechanisms as cancer biomarkers | Patrick Reynolds, Texas Tech University Health Sciences Center |
09/2021 - 08/2026 (Awarded) |
| U01CA253218-01A1 | Pre-analytical variables of bioanalytes affecting the accuracy of PTCL diagnostic and prognostic genetic signatures | Javeed Iqbal, University of Nebraska |
09/2021 - 08/2026 (Awarded) |
| U01CA267985-01 | Optimization of peripheral blood mononuclear cell (PBMC) processing for robust downstream functional immune cell analysis and correlation with therapeutic efficacy | Trisha Wise- Draper, University of Cincinnati |
02/2022 - 01/2027 (Awarded) |
| U01CA271253-01 | Evaluation of Pre-Analytical Factors of Urine Samples for Urine Cancer Cell Cultures (UCCC) — A Non-Invasive Biomarker — in Monitoring Response and Recurrence of Bladder Cancer | Xuefeng Liu, Ohio State University |
03/2022 - 02/2027 (Awarded) |
| U01CA271400-01 | Prostate Needle Biopsies: Impact of Preanalytical Procurement and Processing Variables on the Detection of Gene Expression Signatures of Prostate Cancer Aggressiveness | Alan Pollack, University of Miami School of Medicine |
06/2022 - 05/2027 (Awarded) |
| U01CA275648-01 | Impact of preanalytic procurement and processing variables on the detection of HCC DNA in urine | Ying-Hsiu Su, Baruch S. Blumberg Institute |
02/2023 - 01/2028 (Awarded) |
| U01CA275514-01 | Comprehensive Analysis of Best Practices for Clinical Testing of Malignant Pleural Effusion Specimens | Walter P. Devine, University of California San Francisco |
09/2023 - 08/2028 (Awarded) |
| U01CA271250-01A1 | Advancing the Clinical Translation of Cyst Fluid Assays for Early Detection of Pancreatic Cancer | Kimberly Kirkwood, University of California San Francisco |
09/2023 - 08/2028 (Awarded) |
| 1U01CA271252-01A1 | Enrichment for Tumor-derived Cell-free EBV DNA: Towards a Diagnostic Assay for Endemic Burkitt Lymphoma | Richard Ambinder, Johns Hopkins University |
4/2024 - 4/2029 (Awarded) |
| 1U01CA278865-01A1 | The impact of oxygen exposure on clinical biomarkers - an underrecognized source of pre-analytic variability | Harikrishna Nakshatri, Indiana University Inidanapolis |
5/2024 - 4/2029 (Awarded) |
| 1U01CA288669-01 | Guidelines for processing and storing liquid biopsy samples for functional assays in research and clinical testing | Tothu Vu, Oregon Health and Science University |
9/2024 - 8/2029 (Awarded) |
| 1U01CA281433-01A1 | MetaboCore: Needle biopsy assay of drug sensitivity for solid tumors. | Raymond Yeung, University of Washington |
9/2024 - 8/2029 (Awarded) |
CDP contact:
Dr. Abhi Rao, 240-276-5715, abhi.rao@nih.gov
Dr. Lokesh Agrawal, (240) 276-5718, lokesh.agrawal@nih.gov
Past Funding Opportunities
A complete list of past funding opportunities is available in the Past Funding Opportunities section.
Complementary Funding Opportunities
A list of complementary funding opportunities is available in the Complementary Funding Opportunities section.