RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-11-19
Study Completion:2033-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04564989

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 18 years of age
  2. * T0-T2 N2a-N3 M0 or T3-T4 N0-N3 M0 (AJCC 7th edition)
  3. * Biopsy proven squamous cell carcinoma of the oropharynx or unknown primary
  4. * No prior therapy
  5. * No evidence of distant metastatic disease
  6. * p16 positive = diffuse ≥ 70% tumor cell expression, with at least moderate (2/3+) staining intensity
  7. * Planned for receipt of definitive cancer treatment
  8. * ECOG Performance Status 0-1
  9. * Patients must be deemed able to comply with the treatment plan and follow-up schedule.
  10. * Patients must provide study specific informed consent prior to study entry
  1. * Prior history of radiation therapy to the head and neck
  2. * Prior history of head and neck cancer.
  3. * Inadequate pre-treatment tissue sample for tumor genomic analyses

Contacts and Locations

Study Contact

Chris Hilliard
CONTACT
919-966-4432
chris_hilliard@med.unc.edu
Wendell Yarbrough, MD
CONTACT
919-843-7091
dell@med.unc.edu

Principal Investigator

Wendell Yarbrough, MD
PRINCIPAL_INVESTIGATOR
UNC Chapel Hill

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Wendell Yarbrough, MD, PRINCIPAL_INVESTIGATOR, UNC Chapel Hill

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 Registration Dates

Study Start Date2020-11-19
Study Completion Date2033-11

Study Record Updates

Study Start Date2020-11-19
Study Completion Date2033-11

Terms related to this study

Keywords Provided by Researchers

  • Human Papillomavirus
  • HPV
  • p16
  • Oropharynx
  • OPSCC

Additional Relevant MeSH Terms

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