Microbiome in Head and Neck Squamous Cell Carcinoma Study
This observational study is looking into how the collection of tiny organisms (microbiome) in your body might be linked to head and neck cancer (HNSCC), including cancers of the lip, mouth, and throat. Researchers will use special tests called metagenomic sequencing and metabolic analysis to understand changes in these organisms and their functions. The goal is to see if these changes, called dysbiosis, play a role in HNSCC and what specific processes are involved. You might be able to join if you are 18 to 100 years old, seen at the University of Colorado Health Otolaryngology clinic, and have a diagnosis of oral squamous cell carcinoma (OSCC). The study also includes a control group of age-matched patients without OSCC. The study aims to characterize dysbiosis and metabolomics on Day 1, with an integrative analysis on Day 365. The current status of this study is unclear.
- Study design
- This is an observational study with a planned enrollment of 60 participants. It includes patients with oral squamous cell carcinoma (OSCC) and a control group of age-matched patients without OSCC.
- What's involved
- Participants will undergo metagenomic sequencing and metabolic analysis. The study involves measurements on Day 1 and an integrative analysis on Day 365.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study involves an integrative analysis at Day 365, which suggests a follow-up period of about one year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Microbiome in Head and Neck Squamous Cell Carcinoma
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Shi-Long E Lu, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
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What this trial measures
- Characterize human dysbiosisDay 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 metabolomicsDay 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 discoveryDay 365
We expect to find that specific sets of microbial and host factors interact with each other to promote OSCC.