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Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time (HOTSPOT)

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ClinicalTrials.gov Identifier: NCT01342978
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Oropharyngeal Cancer Human Papillomavirus

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).

Study Design

Study Type : Observational
Actual Enrollment : 242 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time
Study Start Date : October 2009
Primary Completion Date : December 2014
Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

oropharyngeal cancer case
208 oropharyngeal cancer cases were enrolled
partner or spouse of case
110 partners of patients with oropharyngeal cancer were enrolled
A convenience group of 106 non-cancer controls were enrolled at some study sites at cancer screening events

Outcome Measures

Primary Outcome Measures :
  1. HPV DNA detection in oral rinse sample [ Time Frame: baseline ]
    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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Icahn School of Medicine at Mount Sinai
Oregon Health and Science University
Dana-Farber Cancer Institute
Johns Hopkins University
Principal Investigator: Gypsyamber D'Souza, PhD Johns Hopkins Bloomberg School of Public Health
More Information

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
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017

Keywords provided by Gypsyamber D'Souza, Johns Hopkins Bloomberg School of Public Health:

Additional relevant MeSH terms:
Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases