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

NCT04564989 | Recruiting

• 2 other identifiers: LCCC 20441U01DE029754-01
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Human Papillomavirus; HPV; p16; Oropharynx; OPSCC

Outcome Measures

Primary Outcomes (5)

• Recurrence of OPSCC

  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.

  From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years

• Progression-free survival

  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.

  From beginning or end of treatment until date of CT-detected recurrence or date of death, assessed up to 5 years

• Positive Predictive Value

  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.

  Baseline to up to 5 years

• Negative Predictive Value

  Negative Predictive Value (NPV) is defined as probability that patients without two consecutive positive cHPVDNA do not develop OPSCC recurrence during the study period.

  Baseline to up to 5 years

• Quality of Life questionnaire

  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.

  Baseline until recurrence or up to 5 years

Study Arms (1)

HPV+ OPSCC Patients

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HPV+ oropharyngeal squamous cell carcinoma who will receive definitive cancer treatment.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Mayo Clinic: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

ACTIVE NOT RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Trident Medical Center (HCA Healthcare )

North Charleston, South Carolina, 29406, United States

RECRUITING

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell

Study Officials

• Wendell Yarbrough, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori Stravers

CONTACT

919-966-4432; lori_stravers@med.unc.edu

Wendell Yarbrough, MD

CONTACT

919-843-7091; dell@med.unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: September 25, 2020
• Study Start: November 19, 2020
• Primary Completion (Estimated): November 1, 2033
• Study Completion (Estimated): November 1, 2033
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (3)