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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

242 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Oropharyngeal Cancer Human Papillomavirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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oropharyngeal cancer case

208 oropharyngeal cancer cases were enrolled

No interventions assigned to this group

partner or spouse of case

110 partners of patients with oropharyngeal cancer were enrolled

No interventions assigned to this group

control

A convenience group of 106 non-cancer controls were enrolled at some study sites at cancer screening events

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes