Microbiome in Head and Neck Squamous Cell Carcinoma

Trial Title: Microbiome in Head and Neck Squamous Cell Carcinoma

NCT ID: NCT05837221

Condition: Head and Neck Cancer
Lip Cancer
Oral Cancer
Pharynx Cancer

Conditions: Official terms:
Head and Neck Neoplasms
Mouth Neoplasms
Pharyngeal Neoplasms
Lip Neoplasms

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Metagenomic sequencing
Description: 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.
Arm group label: Non Oral Squamous Cell Carcinoma Saliva Sample Group
Arm group label: Non Oral Squamous Cell Carcinoma Stool Sample Group
Arm group label: Oral Squamous Cell Carcinoma Saliva Sample Group
Arm group label: Oral Squamous Cell Carcinoma Stool Sample Group

Intervention type: Diagnostic Test
Intervention name: Metabolic analysis
Description: 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
Arm group label: Non Oral Squamous Cell Carcinoma Saliva Sample Group
Arm group label: Non Oral Squamous Cell Carcinoma Stool Sample Group
Arm group label: Oral Squamous Cell Carcinoma Saliva Sample Group
Arm group label: Oral Squamous Cell Carcinoma Stool Sample Group

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.

Criteria for eligibility:

Study pop:
We aim to enroll 60 patients total - 30 with oral squamous cell carcinoma (OSCC) who are treatment naïve, and 30 who are non-OSCC control patients, who will be age matched to their OSCC counterparts. Estimates show that Dr. Goddard's practice sees approximately 3 treatment naïve OSCC cases per month. We estimate that we can enroll 30-40 of these cases and an equal number of controls in the first 18 months of this study.

Sampling method: Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Locations:

Facility:
Name: University of Colorado Cancer Center

Address:
City: Aurora
Zip: 80045
Country: United States

Status: Recruiting

Contact:
Last name: Ijeoma Eleazu, Pharm.D

Phone: 303-724-6550
Email: ijeoma.eleazu@cuanschutz.edu

Investigator:
Last name: Shi-Long Lu, MD, PhD
Email: Principal Investigator

Start date: December 2024

Completion date: January 2030

Lead sponsor:
Agency: University of Colorado, Denver
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of Colorado, Denver

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05837221