Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time (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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time|
- HPV DNA detection in oral rinse sample [ Time Frame: baseline ] [ Designated as safety issue: No ]Detection of 17 types of HPV DNA in exfoliated oral cells of cases and partners collected using an oral rinse and gargle
Biospecimen Retention: Samples With DNA
Serum, oral rinse/saliva and some tumor samples
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||May 2017|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
oropharyngeal cancer case
180 oropharyngeal cancer cases were enrolled including 166 with HPV-related and 14 with HPV-unrelated cancer.
partner or spouse of case
104 partners of patients with oropharyngeal cancer were enrolled including 97 partners of patients with HPV-related OPC and 7 partners of patients with HPV-unrelated OPC.
A convenience group of non-cancer controls were enrolled at some study sites at cancer screening events
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342978
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21205|
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|Mt Sinai School of Medicine|
|New York, New York, United States, 10029|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Gypsyamber D'Souza, PhD||Johns Hopkins Bloomberg School of Public Health|