NCT05837221

Microbiome in Head and Neck Squamous Cell Carcinoma

Role of Human Microbiome in Head and Neck Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: —

Summary

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

Detailed 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.

Conditions

• Head and Neck Cancer
• Lip Cancer
• Oral Cancer
• Pharynx Cancer

Interventions

Type	Name	Description
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.
DIAGNOSTIC_TEST	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

Timeline

• Start date: 2025-05-23
• Primary completion: 2026-11-01
• Completion: 2028-10-01
• First posted: 2023-05-01
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States