Clinical trial NCT01342978: Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time
Official title: Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oropharyngeal Cancer
Human Papillomavirus
Keywords: HPV
HNSCC
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: Oregon Health and Science University
name: Dana-Farber Cancer Institute
name: Johns Hopkins University
First posted: 2011-04-27
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cohort of cancer patients with matched enrollment of spouses and non-cancer controls

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.

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 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)

Primary outcomes:
measure: HPV DNA detection in oral rinse sample
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Mt Sinai School of Medicine
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Gypsyamber D'Souza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson KS, Wong J, D'Souza G, Riemer AB, Lorch J, Haddad R, Pai SI, Longtine J, McClean M, LaBaer J, Kelsey KT, Posner M. Serum antibodies to the HPV16 proteome as biomarkers for head and neck cancer. Br J Cancer. 2011 Jun 7;104(12):1896-905. doi: 10.1038/bjc.2011.171.
citation: D'Souza G, Gross ND, Pai SI, Haddad R, Anderson KS, Rajan S, Gerber J, Gillison ML, Posner MR. Oral human papillomavirus (HPV) infection in HPV-positive patients with oropharyngeal cancer and their partners. J Clin Oncol. 2014 Aug 10;32(23):2408-15. doi: 10.1200/JCO.2014.55.1341. Epub 2014 Apr 28.