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

Oropharyngeal Cancer Clinical Trial

— HOTSPOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342978
• Other study ID #: HOTSPOT
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: February 28, 2017
• Start date: October 2009
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: January 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Human Papillomavirus
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Mt Sinai School of Medicine	New York	New York
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (5)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Dana-Farber Cancer Institute, Icahn School of Medicine at Mount Sinai, Johns Hopkins University, Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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: 10.10 — View 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV DNA detection in oral rinse sample	Detection of 17 types of HPV DNA in exfoliated oral cells of cases and partners collected using an oral rinse and gargle	baseline