NCT02897427

Throat and Other HPV-Related Cancers in Men: Identifying Them Early

Throat and Other HPV-Related Cancers in Men: Identifying Them Early (TRINITY Study)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: Male
• Age: 50 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This trial studies the screening of human papillomavirus (HPV)-related oropharyngeal and anogenital cancers. Learning the relationship between HPV and cancer risk in men who test positive for HPV antibodies or circulating HPV DNA may help doctors to develop early methods of screening for certain types of cancer, and screening for HPV may help doctors to learn which patients may be at a higher risk for developing certain types of cancer.

Detailed description

PRIMARY SCIENTIFIC OBJECTIVES: I. To determine the association of antibodies to human papillomavirus type 16 (HPV16) early (E) antigens and circulating HPV16 DNA (cHPVDNA) with oral HPV16 prevalence. II. To determine the association of antibodies to HPV16 E antigens and/or cHPVDNA with site-specific HPV16 DNA prevalence, viral persistence, or cellular transformation (cancer and pre-cancer). III. To determine the association of 12-month persistence of oral rinse HPV16 DNA with site-specific oropharyngeal HPV16 DNA prevalence, viral persistence, or cellular transformation (cancer and pre-cancer). EXPLORATORY SCIENTIFIC OBJECTIVE: I. To explore the use of a blood-based point-of-care assay to determine HPV16 E antibody serologic status. OUTLINE: STAGE I: Participants undergo collection of blood and oral rinse samples. STAGE II: Participants complete a head and neck exam with swab of the oropharyngeal mucosa, a thorough oropharyngeal exam including narrow band imaging, collection of oral rinse sample, transcervical ultrasonography of the neck lymph nodes and oropharynx, anoscopy, and complete Papanicolaou/HPV testing. Participants undergo repeat oropharyngeal screening, oral HPV DNA test, oral HPV integration testing, ultrasound, and blood sample collection once every year for 5 years.

Conditions

• Human Papillomavirus Infection

Interventions

Type	Name	Description
OTHER	Biomarker Analysis	Complete HPV testing
PROCEDURE	Biospecimen Collection	Undergo collection of blood and oral gargle samples
PROCEDURE	Ultrasonography	Undergo transcervical ultrasonography

Timeline

• Start date: 2017-03-28
• Primary completion: 2027-03-28
• Completion: 2027-03-28
• First posted: 2016-09-13
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States