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

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Terminated

CT.gov ID

NCT02045186

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Squamous Cell Head and Neck Neoplasms Oropharyngeal Neoplasms	Other: Assessment of Oral HPV Infection	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	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.

Arm

Intervention/Treatment

Other: 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.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥ 18 years of age (no upper age limit)
AnyT, AnyN, M0 squamous cell carcinoma of the oropharynx
Biopsy proven squamous cell carcinoma that is HPV positive via standard pathological assessment of tumor tissues in pathology department at the treating institution
Scheduled for definitive CRT as primary treatment of their oropharynx cancer