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Could a mouth rinse spot hidden HPV cancers in men?

NCT ID NCT02897427

Diagnosis Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is looking for better ways to find HPV-related throat and anal cancers early in men. Researchers are testing whether a blood test or a simple mouth rinse can spot signs of the virus that might lead to cancer. They plan to follow 1,500 men over time to see if these tests can catch cancers sooner than current methods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood or mouth rinse test to catch HPV-related cancers in men at an early, more treatable stage.
What could go wrong
This is an early screening study, not a treatment trial. It may not prove that screening reduces cancer deaths, and false positives could cause unnecessary worry or procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2017

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants willing to have HPV test

Ages

50 to 64 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

human papilloma virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Human papillomavirus infection

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

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