Microbiome in Head and Neck Squamous Cell Carcinoma

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05837221
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Metagenomic sequencing — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    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

Study Details

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

Key Dates

Start date
May 23, 2025
Status verified
Feb 2026
Primary completion
Nov 30, 2026
Completion
Oct 31, 2028

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.).
  • Arm: 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.).

Primary Outcome Measure

Characterize human dysbiosis [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterAuroraColorado80045
Yosr Doghri
[email protected]
(303) 724-6550
Shi-Long Lu, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Colorado Cancer Center· Aurora, CO

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