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

NCT ID: NCT02045186

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-11-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Assessment of Oral HPV Infection

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bhishamjit Chera, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

LCCC1338

Identifier Type: -

Identifier Source: org_study_id