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

NCT01342978 | Completed

• 1 other identifier: HOTSPOT
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 4

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.

Conditions

Oropharyngeal Cancer; Human Papillomavirus

Keywords

HPV; HNSCC

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

oropharyngeal cancer case

208 oropharyngeal cancer cases were enrolled

partner or spouse of case

110 partners of patients with oropharyngeal cancer were enrolled

control

A convenience group of 106 non-cancer controls were enrolled at some study sites at cancer screening events

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• years or older and incident oropharyngeal cancer

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• Oregon Health and Science University: collaborator
• Dana-Farber Cancer Institute: collaborator
• Johns Hopkins University: collaborator

Study Sites (4)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Mt Sinai School of Medicine

New York, New York, 10029, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related 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: 10.1038/bjc.2011.171.

  PMID: 21654689 RESULT

• 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.

  PMID: 24778397 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum, oral rinse/saliva and some tumor samples

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Gypsyamber D'Souza, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: April 27, 2011
• Study Start: October 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-02

Locations

US (4)