Men and Women Offering Understanding of Throat HPV

Active, not recruiting

• Conditions: Human Papilloma Virus; Oropharyngeal Cancer

• Registration Number: NCT03644563
• Lead Sponsor: Johns Hopkins University

Brief Summary

This study will screen people for oncogenic oral Human Papillomavirus (HPV) infection and antibodies to form a cohort of people who may be at increased risk of HPV-oropharyngeal cancer (HPV-OPC). The investigators will follow these individuals prospectively to evaluate oncogenic oral HPV persistence, risk factors, and biomarkers for persistence.

Detailed Description

This study will provide one of the first estimates of long-term oral HPV natural history, and the effect of biologic and behavioral risk factors, including HIV, on this natural history. Phase 1 of the study will screen approximately 1500 people for oncogenic oral HPV biomarkers. Phase 2 of the study will follow only those subjects with oncogenic oral HPV infection and/or HPV serum oncogene antibodies from Phase 1 (and those previously identified as having oncogenic oral HPV infection in a previous study) with annual follow-up for oncogenic oral HPV persistence.

Understanding persistent oncogenic oral HPV infection is the focus of this study. Understanding which factors drive oral HPV infection to become persistent or progress to malignancy is critical to determine who is at high risk for oropharyngeal cancer and may benefit from screening and prevention. It is presumed that persistent oncogenic oral HPV infections are necessary for progression to HPV-OPC.

The study is led by Dr. Amber D'Souza and Dr Carole Fakhry (Johns Hopkins) and participants are being enrolled in Baltimore MD (Johns Hopkins) and in New York (Mt. Sinai).

Study Timeline

• Study Start: 2017-04-03
• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-09
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oncogenic oral HPV infection present or absent in oral rinse sample	Baseline to end of four year follow-up and data abstraction/linkage.	To explore the effects of biologic (microbiome, oral immune response, biologic sex) risk factors for oncogenic oral HPV persistence

Secondary Outcome Measures

Name	Time	Method
HPV16 E6 antibodies present or absent in serum sample	Baseline to end of four year follow-up and data abstraction/linkage.	To explore whether E6 and E7 seropositivity (to HPV16 or any oncogenic HPV) are markers for oncogenic oral HPV persistence among high-risk groups

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States