RecruitingNot Applicable

Microbiome in Head and Neck Squamous Cell Carcinoma

United States60 participantsStarted 2025-05-23

Plain-language summary

This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. Subjects under the age of 18 or over the age of 100
. Subjects unwilling to particiapte

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Characterize human dysbiosis

Timeframe: Day 1

Characterize human metabolomics

Timeframe: Day 1

Integrative multi-omic data analysis and biomarker discovery

Timeframe: Day 365

Trial details

NCT IDNCT05837221

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-11

Contact for this trial

Yosr Doghri

(303) 724-6550 yosr.doghri@cuanschutz.edu

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