RecruitingNCT04564989

Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC

LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

220 participants

Start Date

Nov 19, 2020

Study Type

OBSERVATIONAL

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma, Squamous Cell Oropharyngeal Squamous Cell Carcinoma Oropharynx Squamous Cell Carcinoma

Summary

The primary goal of this study is to examine whether recurrence of HPV-associated OPSCC can be predicted by two factors: 1) mutations in genes called TRAF3 and CYLD, and 2) measurements of circulating HPV DNA in blood plasma. The study will also investigate whether HPV integration is associated with TRAF3 and CYLD mutations, and whether recurrence prediction improves when looking at HPV integration along with TRAF3 and CYLD mutations.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tracks HPV DNA in the blood of patients with HPV-related throat and mouth cancer (oropharyngeal squamous cell carcinoma) to see whether blood-based tests can predict how well cancer treatment is working and detect early recurrence. **You may be eligible if...** - You are 18 or older - You have been diagnosed with squamous cell carcinoma of the throat/tonsils or an unknown primary cancer, confirmed by biopsy - Your tumor tests positive for HPV (p16 positive) - You have not yet received any treatment for this cancer - Your cancer has not spread to distant parts of the body - You are in good health (ECOG 0-1) and planned for definitive cancer treatment **You may NOT be eligible if...** - You have had previous radiation to the head or neck - You have a prior history of head and neck cancer - There is not enough tumor tissue available for analysis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

Mayo Clinic

Rochester, Minnesota, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Trident Medical Center (HCA Healthcare )

North Charleston, South Carolina, United States

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NCT04564989

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