Clinical trial · Observational
Microbiome in Head and Neck Squamous Cell Carcinoma
Role of Human Microbiome in Head and Neck Cancer
NCT05837221CI-TRIAL-00103965recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lip Cancer | Malignant Lip Neoplasm | ALIAS | 0.90 |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Pharynx Cancer | Malignant Pharyngeal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metabolic analysis | Diagnostic Test | — | UNRESOLVED |
| Metagenomic sequencing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Oral Squamous Cell Carcinoma Saliva Sample Group
- description
- Saliva will be collected at least 30 minutes after subjects stop eating, drinking, chewing gum, and smoking. Subjects will be instructed to spit saliva into a collection tube. The saliva will be split into two aliquots, one that is immediately frozen at -80C and one that is mixed 1:1 with pre-reduced tryptic soy broth, L-cysteine, and glycerol then frozen at -80C to preserve the viability of microorganisms.
- interventionNames
- Diagnostic Test: Metagenomic sequencing
- Diagnostic Test: Metabolic analysis
- label
- Non Oral Squamous Cell Carcinoma Saliva Sample Group
- description
- Saliva will be collected at least 30 minutes after subjects stop eating, drinking, chewing gum, and smoking. Subjects will be instructed to spit saliva into a collection tube. The saliva will be split into two aliquots, one that is immediately frozen at -80C and one that is mixed 1:1 with pre-reduced tryptic soy broth, L-cysteine, and glycerol then frozen at -80C to preserve the viability of microorganisms.
- interventionNames
- Diagnostic Test: Metagenomic sequencing
- Diagnostic Test: Metabolic analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.