Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time
18 Years
N/A
Both
Oropharyngeal Cancer, Human Papillomavirus
Trial Information
Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time
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).
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)
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
HPV DNA detection in oral rinse sample
Outcome Description:
Detection of 17 types of HPV DNA in exfoliated oral cells of cases and partners collected using an oral rinse and gargle
Outcome Time Frame:
baseline
Safety Issue:
No
Principal Investigator
Gypsyamber D'Souza, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Johns Hopkins Bloomberg School of Public Health
Authority:
United States: Institutional Review Board
Study ID:
HOTSPOT
NCT ID:
NCT01342978
Start Date:
October 2009
Completion Date:
May 2017
Related Keywords:
- Oropharyngeal Cancer
- Human Papillomavirus
- HPV
- HNSCC
- Oropharyngeal Neoplasms
Name | Location |
|---|---|
| Oregon Health & Science University | Portland, Oregon 97201 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Johns Hopkins Hospital | Baltimore, Maryland 21287 |
| Mt Sinai School of Medicine | New York, New York 10029 |
