NCT02045186

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

Monitoring of Oral HPV Infection in HPV-positive Oropharyngeal Squamous Cell Carcinoma During and After Chemoradiotherapy (CRT)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Oropharyngeal Neoplasms

Interventions

Type	Name	Description
OTHER	Assessment of Oral HPV Infection	Saliva and exfoliated oral epithelial cells will be collected with collection supplies provided by OralDNA Labs. Patients will swish and gargle a saline solution for 30 seconds and expectorate it into a funneled collection tube. The collected specimen will be sent to OralDNA Labs. Three diagnostic tests will be performed on each sample to assess oral HPV infection: 1. Polymerase chain reaction (PCR) for HPV DNA. 2. Fluorescent in-situ hybridization (FISH). 3. Viral expression: The test is based on the measurement of the viral RNA levels by methods of detection of the fluorochrome labeled HPV probes by flow cytometry.

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-03-01
• Completion: 2014-11-01
• First posted: 2014-01-24
• Last updated: 2017-05-04

Locations

1 site across 1 country: United States