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

October 12, 2023 updated by: Erich Sturgis, Baylor College of Medicine

Throat and Other HPV-Related Cancers in Men: Identifying Them Early (TRINITY Study)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

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 Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • Erich Sturgis, MD, MPH

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

50 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants willing to have HPV test

Description

Inclusion Criteria:

  • Stage 1 Inclusion Criteria: United States (US) resident
  • Stage 1 Inclusion Criteria: Fluent in English
  • Stage 1 Inclusion Criteria: Sign an approved informed consent document

  • Stage 2 (longitudinal study) 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

Exclusion Criteria:

  • Stage 1 Exclusion Criteria: Patients with previously documented squamous cell carcinoma of the oropharynx, anus, or penis
  • Stage 1 Exclusion Criteria: Received radiation cancer therapy to the head and neck in the past
  • Stage 1 Exclusion Criteria: On active cancer therapy now or in the past 6 months
  • Stage 1 Exclusion Criteria: Ever had a transplant (stem cell, bone marrow, or solid organ)
  • Stage 1 Exclusion Criteria: Patients who received blood transfusions in the last 6 months
  • Stage 1 Exclusion Criteria: Other medical or psychiatric illness or social situation that would limit study compliance
  • Stage 2 (longitudinal study) Exclusion Criteria: Any seronegative and cvDNA-negative man who tests negative for oral HPV16 DNA by swab and oral rinse at two consecutive follow-up visits will be excluded from further follow-up. Any man who is seropositive, cvDNA-positive, or has evidence of integration at any time will continue to be followed regardless of oral HPV16 status

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: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Biomarker Analysis
Complete HPV testing
Procedure: Biospecimen Collection
Undergo collection of blood and oral gargle samples
Procedure: Ultrasonography
Undergo transcervical ultrasonography
Other Names:
  • Ultrasound
  • 2-Dimensional Grayscale Ultrasound Imaging
  • 2-Dimensional Ultrasound Imaging
  • 2D-US
  • Ultrasound Imaging
  • Ultrasound Test
  • Ultrasound, Medical
  • US

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer detection rate of the seropositive group
Time Frame: Up to 5 years
Will use the proportion equality test to compare the cancer detection rate of the seropositive group using the screening strategy with the historical rate of 0.08 (4/50). To evaluate the performance of the new techniques for early detection, will test whether the proportion of patients diagnosed at stage I, II, or III from the screening strategy is larger than the historical rate of 17.7% using the proportion equality test. Will further compute and compare the pre-cancer detection rates with the historical information.
Up to 5 years
Prevalence of serum antibodies to human papillomavirus (HPV)16 E antigens
Time Frame: Up to 5 years
Will calculate the prevalence of serum antibodies to HPV16 E antigens along with 95% confidence intervals. Will use descriptive statistics to summarize the demographic and sexual behavior characteristics of study participants overall and by HPV16 E antibody status (positive, negative). Logistic regression models will be used to determine the association between serostatus or oral HPV infection status and demographic, socioeconomic, and behavioral factors.
Up to 5 years

Collaborators and Investigators

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

Sponsor

Baylor College of Medicine

Collaborators

University of Texas Southwestern Medical Center
Cancer Prevention Research Institute of Texas

Investigators

  • Principal Investigator: Erich M. Sturgis, Baylor College of Medicine

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.

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)

March 28, 2017

Primary Completion (Estimated)

March 28, 2027

Study Completion (Estimated)

March 28, 2027

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimated)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCM H-49215
  • NCI-2018-02604 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • H-49215 (Other Identifier: Baylor College of Medicine)

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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