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

Active Cooperative Agreement Awarded Last action

Award ID
U01DE034565
Recipient
Awarding agency
Obligated
$6,022,318

Award facts

Assistance listing
93.121 Oral Diseases and Disorders Research
Completion date 34% complete
Place of performance
St. Louis, MO 63110, USA

Award details come from USAspending.gov.

Description

Abstract
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.

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Subawards

Subrecipient Amount Awarded
Centre International De Recherche SUR LE Cancer Scope of Work Subrecipient: International Agency for Research on Cancer (IARC)/Shama Virani Project Title: Validation of a clinically accessible prognostic… $129,226
University Of Pittsburgh - Of The Commonwealth System Of Higher Education STATEMENT OF WORK Subrecipient: University of Pittsburgh – Angela Mazul Project title: Validation of a clinically accessible prognostic biomarker for oropharynx… $39,154
Universitatsklinikum Koln (Aor) Statement of Work Subrecipient: University of Cologne/ Jens Peter Klussmann and Iurii Tolkach Project: Validation of a clinically accessible prognostic… $28,988
Universitatsklinikum Koln (Aor) $28,988
Centre International De Recherche SUR LE Cancer Scope of Work Subrecipient: International Agency for Research on Cancer (IARC)/Shama Virani Project Title: Validation of a clinically accessible prognostic… $75,000
University Of Pittsburgh - Of The Commonwealth System Of Higher Education STATEMENT OF WORK Subrecipient: University of Pittsburgh – Angela Mazul Project title: Validation of a clinically accessible prognostic biomarker for oropharynx… $39,952

Quick answers

Who received award U01DE034565?

U01DE034565 was awarded to The Washington University by National Institute of Dental and Craniofacial Research (National Institutes of Health) on March 12, 2025.

How much is award U01DE034565 worth?

$6,022,318 has been obligated on U01DE034565.

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