Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time
This trial is active, not recruiting.
|Conditions||oropharyngeal cancer, human papillomavirus|
|Sponsor||Johns Hopkins Bloomberg School of Public Health|
|Collaborator||Mount Sinai School of Medicine|
|Start date||October 2009|
|End date||December 2014|
|Trial size||1200 participants|
|Trial identifier||NCT01342978, HOTSPOT|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Baltimore, MD||Johns Hopkins Hospital||no longer recruiting|
|Boston, MA||Dana Farber Cancer Institute||no longer recruiting|
|New York, NY||Mt Sinai School of Medicine||no longer recruiting|
|Portland, OR||Oregon Health & Science University||no longer recruiting|
HPV DNA detection in oral rinse sample
time frame: baseline
Male or female participants at least 18 years old.
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)
|Official title||Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time|
|Principal investigator||Gypsyamber D'Souza, PhD|
|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).|
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