Microbiome in Head and Neck Squamous Cell Carcinoma

Head and Neck Cancer Clinical Trial

Official title:

Role of Human Microbiome in Head and Neck Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837221
• Other study ID #: 23-0016.cc
• Secondary ID: P50CA261605
• Status: Recruiting
• Start date: December 2024
• Est. completion date: January 2030

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: Ijeoma Eleazu, Pharm.D
• Phone: (303) 724-6550
• Email: ijeoma.eleazu[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2030
• Est. primary completion date: January 2028
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Lip Cancer
• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer
• Pharyngeal Neoplasms
• Pharynx Cancer

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Impact of human dysbiosis on OSCC development in mice	Freshly collected saliva and stool samples from 10 subjects of each treatment category will be used to reconstitute microbiota.	Day 10-Day 100
Secondary	Monitor tumor size	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.	Day 10-Day 100