Microbiome in Head and Neck Squamous Cell Carcinoma
Role of Human Microbiome in Head and Neck Cancer
2 other identifiers
observational
60
1 country
1
Brief Summary
This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedStudy Start
First participant enrolled
May 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
February 24, 2026
February 1, 2026
1.4 years
April 19, 2023
February 20, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Characterize human dysbiosis
Stool and saliva samples will be collected from participants, allowing us to reproduce human dysbiosis and analyze whether HNSCC affects one's microbiome composition. Metagenomic sequencing will be conducted through use of DNA extraction, library generation and Illumina sequencing. At least 30 million paired-end 2x150bp metagenomic reads will be generated per sample using the Illumina NovaSeq platform.
Day 1
Characterize human metabolomics
Through our stool and saliva samples we will be able to characterize metagenomic and metabolic signatures in treatment naïve OSCC and non-OSCC patients. Metabolic analysis will be conducted using LC/MS-based metabolic analysis. A targeted approach will quantify a panel of 30 componds 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 and metabolic and immune statuses.
Day 1
Integrative multi-omic data analysis and biomarker discovery
We expect to find that specific sets of microbial and host factors interact with each other to promote OSCC.
Day 365
Secondary Outcomes (2)
Impact of human dysbiosis on OSCC development in mice
Day 10-Day 100
Monitor tumor size
Day 10-Day 100
Study Arms (4)
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
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 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
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Subjects under the age of 18 or over the age of 100
- Subjects unwilling to particiapte
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shi-Long E Lu, MD, PhD
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2023
First Posted
May 1, 2023
Study Start
May 23, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
October 1, 2028
Last Updated
February 24, 2026
Record last verified: 2026-02