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

Johns Hopkins Bloomberg School of Public Health

Status

Completed

Conditions

Oropharyngeal Cancer

Human Papillomavirus

Study type

Observational

Funder types

Other

Identifiers

NCT01342978

HOTSPOT

Details and patient eligibility

About

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.

Full 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).

Enrollment

242 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)