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

18 Years
Open (Enrolling)
Oropharyngeal Cancer, Human Papillomavirus

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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:


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:


Safety Issue:


Principal Investigator

Gypsyamber D'Souza, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins Bloomberg School of Public Health


United States: Institutional Review Board

Study ID:




Start Date:

October 2009

Completion Date:

May 2017

Related Keywords:

  • Oropharyngeal Cancer
  • Human Papillomavirus
  • HPV
  • Oropharyngeal Neoplasms



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