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

Recruiting

• Conditions: Carcinoma, Squamous Cell; Oropharynx Squamous Cell Carcinoma; Oropharyngeal Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma

• Registration Number: NCT04564989
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-14
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-25
• Study Start: 2020-11-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2033-11
• Study Completion: 2033-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• ≥ 18 years of age
• T0-T2 N2a-N3 M0 or T3-T4 N0-N3 M0 (AJCC 7th edition)
• Biopsy proven squamous cell carcinoma of the oropharynx or unknown primary
• No prior therapy
• No evidence of distant metastatic disease
• p16 positive = diffuse ≥ 70% tumor cell expression, with at least moderate (2/3+) staining intensity
• Planned for receipt of definitive cancer treatment
• ECOG Performance Status 0-1
• Patients must be deemed able to comply with the treatment plan and follow-up schedule.
• Patients must provide study specific informed consent prior to study entry

Exclusion Criteria

All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation:

• Prior history of radiation therapy to the head and neck
• Prior history of head and neck cancer.
• Inadequate pre-treatment tissue sample for tumor genomic analyses

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of OPSCC	From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years	Patients will undergo post-treatment CT scans per institutional standard of care to detect cancer recurrence. Status of recurrence of OPSCC will be confirmed based on biopsy.
Positive Predictive Value	Baseline to up to 5 years	Positive Predictive Value (PPV) is defined as probability that patients with two consecutive positive cHPVDNA (i.e., detectable cHPVDNA) really develop OPSCC recurrence during the study period.
Progression-free survival	From beginning or end of treatment until date of CT-detected recurrence or date of death, assessed up to 5 years	Time-to-recurrence will be defined as time lapsed from end (or start) of treatment to first date recurrence (biopsy proven occur later) is detected by CT scans, or death. Otherwise, time-to-recurrence is censored at end of study date.
Negative Predictive Value	Baseline to up to 5 years	Negative Predictive Value (NPV) is defined as probability that patients without two consecutive positive cHPVDNA do not develop OPSCC recurrence during the study period.
Quality of Life questionnaire	Baseline until recurrence or up to 5 years	At specified timepoints before, during, and after treatment, patients will complete a questionnaire comprised of questions from the European Organization for Research and Treatment of Cancer (EORTC) QLQ H\&N35, which is for head and neck cancer patients, and EORTC QLQ C30, which is a general cancer assessment.

Trial Locations

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