University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Location status: Recruiting
Recruiting
NCT Number: NCT05837221
Microbiome in Head and Neck Squamous Cell Carcinoma
This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–100 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
HNSCCis a lethal cancer with a 5-year survival rate below 50%. Although smoking, alcohol intake, and human papillomavirus (HPV) infection are linked to HNSCC, only a small proportion of individuals exposed to these factors develop cancer and not all cases progress. Thus, additional environmental or host factors must contribute to HNSCC. The Study Team and others have observed significant oral dysbiosis in human HNSCC cases, both before and after treatment. This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Metagenomic sequencing
Diagnostic TestShotgun 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 TestMetabolic 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 outcomes
-
Characterize human dysbiosis
Time frame: Day 1
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.
-
Characterize human metabolomics
Time frame: Day 1
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.
-
Integrative multi-omic data analysis and biomarker discovery
Time frame: Day 365
We expect to find that specific sets of microbial and host factors interact with each other to promote OSCC.
Secondary outcomes
-
Impact of human dysbiosis on OSCC development in mice
Time frame: Day 10-Day 100
Freshly collected saliva and stool samples from 10 subjects of each treatment category will be used to reconstitute microbiota.
-
Monitor tumor size
Time frame: Day 10-Day 100
Tumor size (both weight and size) will be monitored using Bli-imaging. These measures will be assessed between treatment groups by ANOVA or analysis of variance testing.
Study contacts
Contact information is provided by the study sponsor or research team.
Kristi Engle Folchert
CONTACT
Yosr Doghri
CONTACT
Sponsors and collaborators
Lead sponsor
University of Colorado, Denver
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Role of Human Microbiome in Head and Neck Cancer
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2028
- First posted
- May 1, 2023
- Registry last updated
- Feb 24, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Completed
Radiation Therapy and Bortezomib and Cetuximab With or Without Cisplatin to Treat Head and Neck Cancer
NCT01445405
Carcinoma, Carcinoma, Squamous
Bethesda, Maryland, United States
View Trial Details
Recruiting
Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers
NCT00568490
Head and Neck Cancer, Head and Neck Cancers
Stanford, California, United States
View Trial Details
Recruiting
Tongue Proactive Strengthening Exercise Program Following Partial/Hemi Glossectomy and Reconstruction
NCT07110142
Head and Neck Cancer, Head and Neck Neoplasms
Cleveland, Ohio, United States
View Trial Details
Recruiting
Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer
NCT06627270
Carcinoma, Carcinoma, Squamous Cell
Cleveland, Ohio, United States
View Trial Details