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

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02045186
• Other study ID #: LCCC1338
• Status: Terminated
• Phase: N/A
• First received: January 22, 2014
• Last updated: May 1, 2017
• Start date: December 2013
• Est. completion date: November 2014

Study information

• Verified date: May 2017
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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: Polymerase chain reaction (PCR) for HPV DNA. Fluorescent in-situ hybridization (FISH). 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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill, Department of Radiation Oncology	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to HPV clearance for patients with HPV-positive OPSCC undergoing CRT		2 years post-CRT of last enrolled patient
Secondary	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
Secondary	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