Recruiting

Microbiome

Sponsor:

University of Colorado, Denver

Code:

NCT05837221

Conditions

Head and Neck Cancer

Lip Cancer

Oral Cancer

Pharynx Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Metagenomic sequencing

Metabolic analysis

Study Details

Brief summary:

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

Conditions

Head and Neck Cancer

Lip Cancer

Oral Cancer

Pharynx Cancer

Study ID

NCT05837221

Start date

May 23, 2025

Status verified date

Feb, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Oral Squamous Cell Carcinoma Saliva Sample Group

Saliva will be collected at least 30 minutes after subjects stop eating, drinking, chewing gum, and smoking. Subjects will be instructed to spit saliva into a collection tube. The saliva will be split into two aliquots, one that is immediately frozen at

-80C and one that is mixed 1:1 with pre-reduced tryptic soy broth, L-cysteine, and glycerol then frozen at -80C to preserve the viability of microorganisms.

Non Oral Squamous Cell Carcinoma Saliva Sample Group

Saliva will be collected at least 30 minutes after subjects stop eating, drinking, chewing gum, and smoking. Subjects will be instructed to spit saliva into a collection tube. The saliva will be split into two aliquots, one that is immediately frozen at

-80C and one that is mixed 1:1 with pre-reduced tryptic soy broth, L-cysteine, and glycerol then frozen at -80C to preserve the viability of microorganisms.

Oral Squamous Cell Carcinoma Stool Sample Group

Stool collection methods may differ depending on the patient. The aim is to collect fresh stool samples, those that are available will be collected during the study visit. If a patient is unable to give a sample at the visit, samples may be collected at home using the OMNIgene-GUT and OMNImet-GUT kits (DNA Genotek, Inc.).

Non Oral Squamous Cell Carcinoma Stool Sample Group

Stool collection methods may differ depending on the patient. The aim is to collect fresh stool samples, those that are available will be collected during the study visit. If a patient is unable to give a sample at the visit, samples may be collected at home using the OMNIgene-GUT and OMNImet-GUT kits (DNA Genotek, Inc.).

Interventions

Metagenomic sequencing

Shotgun metagenomic sequencing will characterize cancer-associated changes in microbial functional capacity and species/strain-level taxonomic profiles. Metagenomics will provide data on microbial functional capacity along with broader taxonomic classifications.

Metabolic analysis

Metabolic analysis will be conducted using LC/MS-based metabolic analysis. A targeted approach will quantify a panel of 30 compounds including Trp pathway products while a non-targeted approach, when applied to both lipid and aqueous phase compounds, will profile relative changes in compounds that may influence host

Primary outcome measure

  • Characterize human dysbiosis [ Time Frame: Day 1 ]
  • Characterize human metabolomics [ Time Frame: Day 1 ]
  • Integrative multi-omic data analysis and biomarker discovery [ Time Frame: Day 365 ]

Central Contacts and Locations

Central contacts

Yosr Doghri

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

Kristi Engle Folchert

(303) 724-9528kristi.englefolchert@cuanschutz.edu

Locations

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Yosr Doghri

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

Principal Investigator:

Shi-Long Lu, MD, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-02-24.