Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time (HOTSPOT)
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Purpose
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.
| Condition |
|---|
|
Oropharyngeal Cancer Human Papillomavirus |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 1200 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| oropharyngeal cancer case |
| partner or spouse of case |
|
control
non-cancer controls are being enrolled at some study sites
|
Detailed 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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
cohort of cancer patients with matched enrollment of spouses and non-cancer controls
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)
Contacts and Locations| 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 |
More Information
Publications:
| Responsible Party: | Gypsyamber D'Souza, Associate Professor, Johns Hopkins Bloomberg School of Public Health |
| ClinicalTrials.gov Identifier: | NCT01342978 History of Changes |
| Other Study ID Numbers: | HOTSPOT |
| Study First Received: | March 7, 2011 |
| Last Updated: | June 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
|
HPV HNSCC |
Additional relevant MeSH terms:
|
Oropharyngeal Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site |
Neoplasms Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013