RecruitingNot Applicable

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

United States220 participantsStarted 2020-11-19

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Recurrence of OPSCC

Timeframe: From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years

Progression-free survival

Timeframe: From beginning or end of treatment until date of CT-detected recurrence or date of death, assessed up to 5 years

Positive Predictive Value

Timeframe: Baseline to up to 5 years

Negative Predictive Value

Timeframe: Baseline to up to 5 years

Quality of Life questionnaire

Timeframe: Baseline until recurrence or up to 5 years

Trial details

NCT IDNCT04564989

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2033-11

Contact for this trial

Lori Stravers

919-966-4432 lori_stravers@med.unc.edu

View on ClinicalTrials.gov More Oropharyngeal Squamous Cell Carcinoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Recurrence of OPSCC

Timeframe: From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years

Progression-free survival

Timeframe: From beginning or end of treatment until date of CT-detected recurrence or date of death, assessed up to 5 years

Positive Predictive Value

Timeframe: Baseline to up to 5 years

Negative Predictive Value

Timeframe: Baseline to up to 5 years

Quality of Life questionnaire

Timeframe: Baseline until recurrence or up to 5 years