Microbiome in Head and Neck Squamous Cell Carcinoma

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Pharynx Cancer; Lip Cancer; Oral Cancer; Head and Neck Cancer

Treatments: Diagnostic Test: Metagenomic sequencing; Diagnostic Test: Metabolic analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05837221

23-0016.cc

P50CA261605 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 4 patient groups

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.

Treatment:

Diagnostic Test: Metabolic analysis

Diagnostic Test: Metagenomic sequencing

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.

Treatment:

Diagnostic Test: Metabolic analysis

Diagnostic Test: Metagenomic sequencing

Oral Squamous Cell Carcinoma Stool Sample Group

Description:

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.).

Treatment:

Diagnostic Test: Metabolic analysis

Diagnostic Test: Metagenomic sequencing

Non Oral Squamous Cell Carcinoma Stool Sample Group

Description:

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.).

Treatment:

Diagnostic Test: Metabolic analysis

Diagnostic Test: Metagenomic sequencing