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

Not Applicable

Terminated

• Conditions: Carcinoma, Squamous Cell; Head and Neck Neoplasms; Oropharyngeal Neoplasms
• Interventions: Other: Assessment of Oral HPV Infection

• Registration Number: NCT02045186
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Primary Completion: 2014-03
• Study Completion: 2014-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assessment of Oral HPV Infection	Assessment of Oral HPV Infection	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with HPV-positive OPSCC undergoing CRT who are clear of their oral HPV infection at each time-point	2 years post-CRT of last enrolled patient

Secondary Outcome Measures

Name	Time	Method
Time to HPV clearance for patients with HPV-positive OPSCC undergoing CRT	2 years post-CRT of last enrolled patient
Number of aneuploidy cells as measured by FISH (Florescent in-situ hybridization) and the mRNA copy number for HPV E6 and HPV E7 at each time-point	2 years post-CRT of last enrolled patient
Clinical outcomes of interest (local control, loco-regional control, distant metastasis-free survival, and overall survival (OS)) in patients with HPV-positive OPSCC undergoing CRT	2 years post-CRT of last enrolled patient

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill, Department of Radiation Oncology; 🇺🇸 Chapel Hill, North Carolina, United States