Men and Women Offering Understanding of Throat HPV (MOUTH)

March 18, 2024 updated by: Johns Hopkins Bloomberg School of Public Health

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Target sample size: 1325 (phase 1), ~250 (phase 2) Inclusion of women and minorities: Primary enrollment is restricted to men, given their higher risk of infection (see eligibility criteria). However, the investigators expect to enroll women with cervical dysplasia and partners of patients with HPV-related cancer (~125 expected women enrollees). Enrollment is across many different sources (geographically, and by clinic type), and is inclusive of diverse racial and ethnic backgrounds. Enrollment is not stratified by race but the investigators expect to enroll at least 175 minorities in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Follow-up
Those subjects with oncogenic oral HPV infection and/or HPV oncogene serum antibodies from screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncogenic oral HPV infection present or absent in oral rinse sample
Time Frame: 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
Baseline to end of four year follow-up and data abstraction/linkage.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV16 E6 antibodies present or absent in serum sample
Time Frame: 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
Baseline to end of four year follow-up and data abstraction/linkage.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Icahn School of Medicine at Mount Sinai
National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Amber D'Souza, PhD, Bloomberg Johns Hopkins School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2017

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00119537
  • R35DE026631 (U.S. NIH Grant/Contract)
  • IRB00007636 (Other Identifier: JHSPH IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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