Investigating the role of microbiome in head and neck cancer
Official title: Role of Human Microbiome in Head and Neck Cancer
Run by University of Colorado, Denver · NCT05837221 · Data updated 2026-11-12
This study is trying to see if changes in the bacteria in the mouth are linked to head and neck cancer by comparing patients with the cancer to people without it.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | May 23, 2025 |
| Main results expected | November 2026 |
| Study ends | October 2028 |
| Registry record updated | February 24, 2026 |
| Trial ID | NCT05837221 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older diagnosed with oral squamous cell carcinoma who are being evaluated at the University of Colorado Health.
✕Probably not a fit
Patients under 18 or over 100 years old, as well as those unwilling to participate, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the relationship between dysbiosis and head and neck squamous cell carcinoma (HNSCC). It will assess whether changes in the oral microbiome contribute to the development of HNSCC and investigate the underlying molecular mechanisms involved. The study will involve metagenomic sequencing and metabolic analysis to gather comprehensive data on the microbiome of affected individuals compared to a control group. Participants will include patients diagnosed with oral squamous cell carcinoma and age-matched controls without the diagnosis.
Why it matters
Potential benefit: If successful, this study could lead to new insights into the prevention and treatment of head and neck cancers by targeting microbiome-related factors.
How similar studies have gone: While the role of the microbiome in various cancers is being explored, this specific investigation into HNSCC and its molecular mechanisms is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University of Colorado Cancer Center
Aurora, Colorado, United States Recruiting
Study contacts
- Principal investigator: Shi-Long E Lu, MD, PhD — University of Colorado, Denver
- Study coordinator: Yosr Doghri
- Email: yosr.doghri@cuanschutz.edu
- Phone: (303) 724-6550
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.