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

April 16, 2024 updated by: UNC Lineberger Comprehensive Cancer Center

LCCC 2044: 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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Wendell Yarbrough, MD
  • Phone Number: 919-843-7091
  • Email: dell@med.unc.edu

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
        • Principal Investigator:
          • Wendell Yarbrough, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years
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.
From beginning or end of treatment until date of CT-detected recurrence or date of death, assessed up to 5 years
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.
Baseline to up to 5 years
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.
Baseline to up to 5 years
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.
Baseline until recurrence or up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

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

Investigators

  • Principal Investigator: Wendell Yarbrough, MD, UNC Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2020

Primary Completion (Estimated)

November 1, 2033

Study Completion (Estimated)

November 1, 2033

Study Registration Dates

First Submitted

August 14, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC 2044
  • 1U01DE029754-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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