Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
180 oropharyngeal cancer cases were enrolled including 166 with HPV-related and 14 with HPV-unrelated cancer.
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

Primary Outcomes

Measure
HPV DNA detection in oral rinse sample
time frame: baseline

Eligibility Criteria

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)

Additional Information

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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health.