Microbiome in Head and Neck Squamous Cell Carcinoma

NCT ID: NCT05837221

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2030-01-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Oral Squamous Cell Carcinoma Saliva Sample Group

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.

Metagenomic sequencing

Intervention Type: DIAGNOSTIC_TEST

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.

Metabolic analysis

Intervention Type: DIAGNOSTIC_TEST

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

Non Oral Squamous Cell Carcinoma Saliva Sample Group

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.

Metagenomic sequencing

Intervention Type: DIAGNOSTIC_TEST

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.

Metabolic analysis

Intervention Type: DIAGNOSTIC_TEST

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

Oral Squamous Cell Carcinoma Stool Sample Group

Stool collection methods may differ depending on the patient. The aim is to collect fresh stool samples, those that are available will be collected during the study visit. If a patient is unable to give a sample at the visit, samples may be collected at home using the OMNIgene-GUT and OMNImet-GUT kits (DNA Genotek, Inc.).

Metagenomic sequencing

Intervention Type: DIAGNOSTIC_TEST

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.

Metabolic analysis

Intervention Type: DIAGNOSTIC_TEST

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

Non Oral Squamous Cell Carcinoma Stool Sample Group

Stool collection methods may differ depending on the patient. The aim is to collect fresh stool samples, those that are available will be collected during the study visit. If a patient is unable to give a sample at the visit, samples may be collected at home using the OMNIgene-GUT and OMNImet-GUT kits (DNA Genotek, Inc.).

Metagenomic sequencing

Intervention Type: DIAGNOSTIC_TEST

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.

Metabolic analysis

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shi-Long E Lu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Cancer Center

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yosr Doghri

Role: CONTACT

yosr.doghri@cuanschutz.edu

(303) 724-6550

Kristi Engle Folchert

Role: CONTACT

kristi.englefolchert@cuanschutz.edu

(303) 724-9528

Facility Contacts

Yosr Doghri

Role: primary

yosr.doghri@cuanschutz.edu

(303) 724-6550

Other Identifiers

P50CA261605

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-0016.cc

Identifier Type: -

Identifier Source: org_study_id