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NCT Number: NCT04564989

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

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.

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Key information

Conditions

Oropharyngeal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Oropharynx Squamous Cell Carcinoma Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Recurrence of OPSCC

    Time frame: 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.

  2. Progression-free survival

    Time frame: 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.

  3. Positive Predictive Value

    Time frame: 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.

  4. Negative Predictive Value

    Time frame: 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.

  5. Quality of Life questionnaire

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lori Stravers

CONTACT

[email protected]

919-966-4432

Wendell Yarbrough, MD

CONTACT

[email protected]

919-843-7091

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Mayo Clinic
  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2033
Study completion
2033
First posted
Sep 25, 2020
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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