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

NCT02045186 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-05-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Bhishamjit Chera, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-03-31
Completion
2014-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02045186 on ClinicalTrials.gov