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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
Oregon Health and Science University
Dana-Farber Cancer Institute
Johns Hopkins University
Information provided by (Responsible Party):
Gypsyamber D'Souza, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01342978
First received: March 7, 2011
Last updated: March 30, 2015
Last verified: March 2015
  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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • 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
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
control
A convenience group of non-cancer controls were enrolled at some study sites at cancer screening events

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
Study Population

cohort of cancer patients with matched enrollment of spouses and non-cancer controls

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342978

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
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
Investigators
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: March 30, 2015
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
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 27, 2015