Microbiome in Head and Neck Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metagenomic sequencing, Metabolic analysis.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer, Lip Cancer, Oral Cancer, Pharynx Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Role of Human Microbiome in Head and Neck Cancer
Overview
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.
Interventions
- 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
Primary outcome measures
- Characterize human dysbiosis [Time frame: Day 1]
- Characterize human metabolomics [Time frame: Day 1]
- Integrative multi-omic data analysis and biomarker discovery [Time frame: Day 365]
Secondary outcome measures (2)
- Impact of human dysbiosis on OSCC development in mice [Time frame: Day 10-Day 100]
- Monitor tumor size [Time frame: Day 10-Day 100]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Colorado Cancer Center — Aurora
Identifiers
NCT: NCT05837221 · 23-0016.cc · P50CA261605