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

UNC Lineberger Comprehensive Cancer Center220 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

220

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Mayo Clinic

Rochester, Minnesota, United States

ACTIVE_NOT_RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

RECRUITING

Trident Medical Center (HCA Healthcare )

North Charleston, South Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline until recurrence or up to 5 years