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Scientists investigate whether tiny microbes fuel head and neck tumors

NCT ID NCT05837221

Knowledge-focused Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether changes in the bacteria living in your mouth and gut (the microbiome) are linked to head and neck cancer. Researchers will collect stool and saliva samples from 60 people—half with cancer and half without—to compare their microbial makeup. The goal is to understand if these microbes play a role in cancer development, which could lead to new ways to diagnose or treat the disease in the future.

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 research could reveal how bacteria in the mouth and gut influence head and neck cancer, potentially pointing to new ways to detect or treat the disease.
What could go wrong
This is an early observational study with only 60 participants. It is designed to gather information, not to test a treatment, so direct benefits for patients are not expected.

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 60 people

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

Started

May 2025

Expected to finish

Oct 2028

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

We aim to enroll 60 patients total - 30 with oral squamous cell carcinoma (OSCC) who are treatment naïve, and 30 who are non-OSCC control patients, who will be age matched to their OSCC counterparts. Estimates show that Dr. Goddard's practice sees approximately 3 treatment naïve OSCC cases per month. We estimate that we can enroll 30-40 of these cases and an equal number of controls in the first 18 months of this study.

Ages

18 to 100 years

Sex

Anyone

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: 1. Subjects equal to or above the age of 18. 2. Patients who are seen and evaluated by a provider within the adult Otolaryngology clinic at the University of Colorado Health. 3. Patients that present with a diagnosis of OSCC. 4. An equal number of age-matched patients who are visiting the clinic for reasons other than OSCC diagnoses, as the control group. 5. Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: 1. Subjects under the age of 18 or over the age of 100 2. Subjects unwilling to particiapte

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms lip and oral cavity carcinoma lip cancer Mouth Neoplasms oral cavity squamous cell carcinoma pharynx cancer

As listed by the trial registrant

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

Head and neck cancer Lip cancer Oral cancer Pharynx cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

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