Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time

Completed

• Conditions: Oropharyngeal Cancer; Human Papillomavirus

• Registration Number: NCT01342978
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

This research is being done to understand more about a sexually transmitted virus called Human papillomavirus (HPV) in people with oropharyngeal cancer and their partners.

Detailed Description

This study evaluates oral HPV infection and risk factors in people with head and neck cancer and their partners or spouses. The study focuses on oropharyngeal cancer patients and includes patients with HPV-associated and HPV-unassociated disease. A comparison group of people without cancer (controls) are also being enrolled. Couples are followed longitudinally and there is a repository of study samples. It is hoped that this research will help us understand risk factors for oral HPV infection, persistence and transmission as well as researching biomarkers for HPV-associated oral cancer and survival.

The study is led by Dr Amber D'Souza (Johns Hopkins) and laboratory testing for the study is performed in the laboratory of study co-investigator Dr Maura Gillison (Ohio University). The study biorepository is led by Dr karen Anderson (Arizona State). Participants are being enrolled at four sites across the United States including: Mt Sinai (site PI Dr Marshall Posner), Johns Hopkins (site PI Dr Sara Pai), Dana Farber Cancer Institute (site PI Dr Robert Haddad) and Oregon Health and Science University (site PI Dr Neil Gross).

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-04-26
• Study First Posted: 2011-04-27
• Primary Completion: 2014-12
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• 18 years or older and incident oropharyngeal cancer

Exclusion Criteria

• Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent
• Cancer patients with a history of organ transplant, autoimmune disorder treated with steroids or immunosuppressive drug, lymphoma, leukemia or bone marrow transplant are also ineligible (partners with these conditions are eligible)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HPV DNA detection in oral rinse sample	baseline	Detection of 17 types of HPV DNA in exfoliated oral cells of cases and partners collected using an oral rinse and gargle

Trial Locations

Locations (4)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Mt Sinai School of Medicine; 🇺🇸 New York, New York, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States