Men and Women Offering Understanding of Throat HPV

Human Papilloma Virus Clinical Trial

— MOUTH  

Official title:

Impacting the Oral HPV Continuum: MOUTH Study (Men and Women Offering Understanding of Throat HPV)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03644563
• Other study ID #: IRB00119537
• Secondary ID: R35DE026631IRB00
• Status: Active, not recruiting
• Start date: April 3, 2017
• Est. completion date: June 2028

Study information

• Verified date: March 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: June 2028
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Participants in the Phase 1 Screening

Inclusion criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• 18 and older (enrollment at most sites will be restricted to 30 and older since this demographic has the highest prevalence of infection; however, individuals and/or partners of someone with an HPV-related cancer, for example, are at increased risk so will be enrolled in the larger age range).

• Willing to be contacted to arrange follow-up visits, if determined to be eligible for phase 2

• Ability to understand and the willingness to sign a written informed consent document

In addition, individuals must meet at least one of the following criteria:

• Male, aged 30 and older, with 2 or more lifetime oral sex

• History of anal or genital dysplasia or cancer

• Partners of someone with an HPV-related cancer (HPV-positive OPC, anal cancer or genital cancer)

• Known oncogenic HPV-positive biomarker from prior studies or testing, regardless of number of partners.

Exclusion criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

• Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent.

• Participants who do not speak English cannot enroll because the consent and study survey are only available in English. However, if there is a hearing, literacy or minor fluency issue and the participant requests assistance from a family member or the study coordinator, this individual may still enroll and receive this assistance to ensure they fully hear and understand everything being asked.

• History of head and neck cancer

Participants in the Phase 2 Follow-Up

Inclusion criteria:

• Oncogenic oral HPV infection and/or HPV serum oncogenic antibodies detected in phase 1

• Willingness to complete annual follow up visits

Exclusion criteria:

• Unable to complete annual follow up visits

Related Conditions & MeSH terms

• Human Papilloma Virus
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms
• Papilloma

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Icahn School of Medicine at Mount Sinai, National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (2)

D'Souza G, Clemens G, Troy T, Castillo RG, Struijk L, Waterboer T, Bender N, Pierorazio PM, Best SR, Strickler H, Wiley DJ, Haddad RI, Posner M, Fakhry C. Evaluating the Utility and Prevalence of HPV Biomarkers in Oral Rinses and Serology for HPV-related — View Citation

D'Souza G, Tewari SR, Troy T, Waterboer T, Struijk L, Castillo R, Wright H, Shen M, Miles B, Johansson M, Robbins HA, Fakhry C. Prevalence of oral and blood oncogenic human papillomavirus biomarkers among an enriched screening population: Baseline results — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oncogenic oral HPV infection present or absent in oral rinse sample	To explore the effects of biologic (microbiome, oral immune response, biologic sex) risk factors for oncogenic oral HPV persistence	Baseline to end of four year follow-up and data abstraction/linkage.
Secondary	HPV16 E6 antibodies present or absent in serum sample	To explore whether E6 and E7 seropositivity (to HPV16 or any oncogenic HPV) are markers for oncogenic oral HPV persistence among high-risk groups	Baseline to end of four year follow-up and data abstraction/linkage.

External Links

•   MOUTH Study Website