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

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

2017-03-28

Study Completion Date

2027-03-28

Brief Summary

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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.

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Detailed Description

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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

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Human Papillomavirus Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Screening (specimen collection, HPV testing)

STAGE I: Participants fill out a survey and undergo collection of blood and oral rinse samples.

STAGE II: Participants complete a head and neck exam by using brushing 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, penile exam, 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. Select participants will provide oral rinse sample by mail every six months.

Biomarker Analysis

Intervention Type OTHER

Complete HPV testing

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood and oral gargle samples

Ultrasonography

Intervention Type PROCEDURE

Undergo transcervical ultrasonography

Interventions

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Biomarker Analysis

Complete HPV testing

Intervention Type OTHER

Biospecimen Collection

Undergo collection of blood and oral gargle samples

Intervention Type PROCEDURE

Ultrasonography

Undergo transcervical ultrasonography

Intervention Type PROCEDURE

Other Intervention Names

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2-Dimensional Grayscale Ultrasound Imaging 2-Dimensional Ultrasound Imaging 2D-US Ultrasound Ultrasound Imaging Ultrasound Test Ultrasound, Medical US

Eligibility Criteria

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Inclusion Criteria

* Eligible for and enrolled in Stage 1
* Test positive to HPV16 E antibodies; be identified as a negative control; test positive for oral HPV16 infection by oral rinse; or test positive for cvDNA
* Sign an approved informed consent document

Minimum Eligible Age

50 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Erich Sturgis

Professor and Vice-Chair of Clinical Affairs, Dept of Otolaryngology-Head and Neck Surgery; Brown Foundation Endowed Chair; Head, Neck, & Thyroid Cancer Multidisciplinary Program Director

Responsibility Role PRINCIPAL_INVESTIGATOR