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Validation of a clinically accessible prognostic biomarker for oropharynx cancer using molecular and spatial data

Award Number: U01DE034565
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: 03/12/2025
PERIOD OF PERFORMANCE END DATE: 12/31/2029

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Validation of a clinically accessible prognostic biomarker for oropharynx cancer using molecular and spatial data - PROJECT SUMMARY Oropharynx cancer (OPC) incidence has risen annually by 2.7% in the U.S. and is expected to be among the most common cancers over the next few decades. The vast majority of OPC is now reliably linked to human papillomavirus exposure (HPV+). Because HPV+ OPC typically has favourable outcomes, de-intensification trials have been aggressively advanced to minimize treatment-related toxicity and morbidity. However, while most patients respond well and might benefit from treatment de-escalation, there remain 10-38% of HPV+ OPC patients who experience adverse outcomes including recurrence and death. Unfortunately, current de- escalation trials remain indiscriminate in their ability to stratify these patients as there is no marker that is available to classify HPV+ patients further than the dichotomous measure of HPV positivity. The goal of this proposal is to validate a novel prognostic biomarker that captures tumor biology and heterogeneity in >1,000 diverse HPV+ OPC patients from the United States, Europe and South America to guide clinical decision-making and reduce treatment-related toxicity and morbidity. The specific aims are to 1) analytically validate HPVhet scores to establish reliability across diverse patient populations, establish risk groups to maximise prognostic accuracy, and externally validate informative HPVhet scores on outcomes; and 2) translate the HPVhet score as an imaging biomarker through detection from standard hematoxylin and eosin (H&E) stains through optimization of a validated, advanced machine-learning algorithm, OPSCCNet. The OPSCCNet algorithm will combine the molecular HPVhet score with related spatial features for effective interpretation of HPVhet on a spatial scale. Validation of a clinically useful prognostic biomarker that utilizes molecular and spatial data to capture tumor heterogeneity in >1,000 diverse HPV+ OPC patients could lead to a paradigm shift in how these patients are treated and in their quality of life after treatment. Importantly, the inclusion of a range of clinical settings and patient populations ensures scientific rigor and health equity in these findings.


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 = $606,031 )
2026	2026	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Oral Diseases and Disorders Research	004	2	3/3/2026	SUPPLEMENT FOR EXPANSION	$2,898
2026	2026	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Oral Diseases and Disorders Research	005	2	3/3/2026	SUPPLEMENT FOR EXPANSION	$41,296
2026	2026	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Oral Diseases and Disorders Research	003	2	3/3/2026	NON-COMPETING CONTINUATION	$16,408
2026	2026	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Oral Diseases and Disorders Research	001	2	1/28/2026	SUPPLEMENT FOR EXPANSION	$26,090
2026	2026	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Oral Diseases and Disorders Research	002	2	1/29/2026	SUPPLEMENT FOR EXPANSION	$87,930
2026	2026	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Oral Diseases and Disorders Research	000	2	1/20/2026	NON-COMPETING CONTINUATION	$431,409
2026	2025	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Oral Diseases and Disorders Research	006	1	3/19/2026	NEW	$0
														Subtotal = $606,031

Issue Date FY: 2025 ( Subtotal = $638,903 )
2025	2025	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Oral Diseases and Disorders Research	004	1	8/15/2025	NEW	$32,872
2025	2025	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Oral Diseases and Disorders Research	001	1	8/5/2025	NEW	-$136,860
2025	2025	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Oral Diseases and Disorders Research	002	1	8/5/2025	SUPPLEMENT FOR EXPANSION	$75,000
2025	2025	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Oral Diseases and Disorders Research	003	1	8/6/2025	SUPPLEMENT FOR EXPANSION	$28,988
2025	2025	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Oral Diseases and Disorders Research	000	1	3/12/2025	NEW	$638,903
2025	2025	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Oral Diseases and Disorders Research	005	1	9/8/2025	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $638,903

Grand Total All Awards = $1,244,934

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Validation of a clinically accessible prognostic biomarker for oropharynx cancer using molecular and spatial data

Award Number: U01DE034565

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: 03/12/2025

PERIOD OF PERFORMANCE END DATE: 12/31/2029

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