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Biomarker Approach to Screening for the early detection of HPV-related Oropharyngeal Cancer (BASH OPC)

Award Number: U01DE033329
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/04/2023
PERIOD OF PERFORMANCE END DATE: 06/30/2028

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Biomarker Approach to Screening for the early detection of HPV-related Oropharyngeal Cancer (BASH OPC) - ABSTRACT Oropharyngeal cancer (OPC) incidence is significantly increasing with most cases (~80%) caused by human papillomavirus (HPV) infection type 16. The majority of OPC cases are diagnosed late and require intensive chemo-radiation causing significant morbidity, life-long disabilities, and mortality. Early OPC detection is currently the most viable secondary prevention approach with the potential to vastly improve outcomes for OPC patients. We completed a series of studies focused on developing an oral gargle biomarker panel suitable for early OPC detection that can be measured in a single oral gargle specimen, and can discriminate between early OPC (T1- 2 N0-1 [small tumors with a single ipsilateral node ≤3 cm]) cases and controls in two different case-control sets. In a follow-up study the biomarker panel specificity and sensitivity was improved (AUC = 0.935) with a genome- wide methylation array discovery approach. This resulted in panel expansion to include oral HPV 16 status and 13 differentially methylated host gene CpG sites. We are now poised to advance this oral gargle biomarker panel to the second phase of biomarker development. We propose to leverage existing biorepositories of early OPC cases and research infrastructure at two cancer centers to efficiently advance clinical assay development and validation. Our goal is to validate a non-invasive diagnostic biomarker panel to detect OPC early. The central hypothesis is that we can distinguish early OPC cases from cancer-free individuals using biomarkers related to HPV and host epigenetic alterations, thereby identifying tumors that can be effectively and safely treated with a single modality where survival is highest. As we are keenly aware that this is an evolving field, we will also conduct preliminary evaluation of these and other biomarkers as the literature evolves. The Primary Aim is to estimate the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early OPC cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race, and tobacco from the Moffitt Cancer Center and the UPMC Hillman Cancer Center. Secondary Aims include assessing inter- and within-laboratory biomarker concordance and reliability, factors associated with the biomarker panel separately among cases and controls, and the performance of other differentially methylated host genes (e.g., SYNGR3) and/or oral tumor-tissue modified HPV DNA to detect OPC early. This is an innovative approach to OPC early detection, using a non-invasive specimen readily obtained (e.g., in routine dental practice). The approach builds on existing clinical/epidemiologic infrastructure, well annotated biorepository and data from OPC cases and controls, and strong preliminary data. Our research team has the experience and expertise to successfully implement the proposed study. Results will inform the design of a large definitive prospective screening trial of a biomarker panel measured in a non-invasive specimen among high-risk individuals to shift OPC diagnosis from late to early disease.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Oral Diseases and Disorders Research	000	3	3/4/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $715,985 )
2025	2025	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Oral Diseases and Disorders Research	001	3	6/27/2025	NON-COMPETING CONTINUATION	$715,985
2025	2024	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Oral Diseases and Disorders Research	000	2	5/9/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $715,985

Issue Date FY: 2024 ( Subtotal = $702,649 )
2024	2024	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Oral Diseases and Disorders Research	002	2	6/12/2024	NON-COMPETING CONTINUATION	$702,649
2024	2023	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Oral Diseases and Disorders Research	000	1	1/4/2024	NEW	$0
2024	2023	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Oral Diseases and Disorders Research	001	1	1/10/2024	NEW	$0
														Subtotal = $702,649

Issue Date FY: 2023 ( Subtotal = $727,078 )
2023	2023	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Oral Diseases and Disorders Research	000	1	9/4/2023	NEW	$727,078
														Subtotal = $727,078

Grand Total All Awards = $2,145,712

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Biomarker Approach to Screening for the early detection of HPV-related Oropharyngeal Cancer (BASH OPC)

Award Number: U01DE033329

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/04/2023

PERIOD OF PERFORMANCE END DATE: 06/30/2028

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