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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT04564989
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Nov 19, 2020
Status verified
Apr 2026
Primary completion
Nov 30, 2033
Completion
Nov 30, 2033

Study Design

Enrollment
220 participants (estimated)

Arms

  • Arm: HPV+ OPSCC Patients
    Patients with p16+ squamous cell carcinoma of the oropharynx (or unknown primary) who will receive definitive cancer treatment.

Primary Outcome Measure

Recurrence of OPSCC [ Time Frame: From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Tuvara King
[email protected]
919-966-4432
Wendell Yarbrough, MD (PRINCIPAL_INVESTIGATOR)
Trident Medical Center (HCA Healthcare )North CharlestonSouth Carolina29406
Vera Markovic
[email protected]
843-998-2819
David Neskey, MD
[email protected]
843-998-2819
David Neskey, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Mayo Clinic· Rochester, MNUniversity of North Carolina at Chapel Hill· Chapel Hill, NCTrident Medical Center (HCA Healthcare )· North Charleston, SC

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