Clinical trial NCT04564989: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
Official title: LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oropharyngeal Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Head and Neck Squamous Cell Carcinoma
Oropharynx Squamous Cell Carcinoma
Keywords: Human Papillomavirus
HPV
p16
Oropharynx
OPSCC
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2020-09-25
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HPV+ oropharyngeal squamous cell carcinoma who will receive definitive cancer treatment.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of OPSCC
timeFrame: From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years
measure: 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
measure: Positive Predictive Value
timeFrame: Baseline to up to 5 years
measure: Negative Predictive Value
timeFrame: Baseline to up to 5 years
measure: Quality of Life questionnaire
timeFrame: Baseline until recurrence or up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: North Charleston
country: United States
facility: Trident Medical Center (HCA Healthcare )
state: South Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Wendell Yarbrough, MD
role: PRINCIPAL_INVESTIGATOR
References: