Men and Women Offering Understanding of Throat HPV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-03

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Oropharyngeal Cancer Human Papilloma Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Follow-up

Those subjects with oncogenic oral HPV infection and/or HPV oncogene serum antibodies from screening.

No interventions assigned to this group

Eligibility Criteria

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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.

* Oncogenic oral HPV infection and/or HPV serum oncogenic antibodies detected in phase 1
* Willingness to complete annual follow up visits

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

• Unable to complete annual follow up visits

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes