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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Oropharyngeal Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

UNC Lineberger Comprehensive Cancer Center,

Wendell Yarbrough, MD, PRINCIPAL_INVESTIGATOR, UNC Chapel Hill

Study Record Dates

2033-11