Monitoring of Oral Human Papillomavirus Infection (HPV) in HPV-positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)

UNC Lineberger Comprehensive Cancer Center

Status: Terminated

Conditions: Carcinoma, Squamous Cell; Oropharyngeal Neoplasms; Head and Neck Neoplasms

Treatments: Other: Assessment of Oral HPV Infection

Study type: Interventional

Funder types: Other

Identifiers

NCT02045186

LCCC1338

Details and patient eligibility

About

The purpose of this research study is to determine whether and when patients with human papilloma virus positive squamous cell cancer of the oropharynx treated with radiation and chemotherapy clear their human papilloma virus infection.

Enrollment: 1 patient

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 18 years of age (no upper age limit)
2. AnyT, AnyN, M0 squamous cell carcinoma of the oropharynx
3. Biopsy proven squamous cell carcinoma that is HPV positive via standard pathological assessment of tumor tissues in pathology department at the treating institution
4. Scheduled for definitive CRT as primary treatment of their oropharynx cancer

Exclusion criteria

1. Prior history of radiation therapy to the head and neck
2. Prior history of mucosal head and neck cancer.
3. Not willing or able to comply with study specific procedures

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Assessment of Oral HPV Infection

Other group

Description:

Oral HPV infection will be assessed 14 times, once prior to starting CRT, weekly during CRT, and then serially post-treatment: 4-8 weeks, 3 months, 6 months, 12 months, 18 months, 24 months. Patients will provide samples of their saliva and exfoliated epithelial cells at these timepoints. Samples will be collected with supplies provided by and analyzed by OralDNA Labs.

Treatment:

Other: Assessment of Oral HPV Infection