Health TrialsbyHealthPanel

Microbiome in Head and Neck Squamous Cell Carcinoma

ConditionsHead and Neck CancerLip CancerOral CancerPharynx Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Colorado, Denver

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Subjects under the age of 18 or over the age of 100

Subjects unwilling to particiapte

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Metagenomic sequencing

    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

    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

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Oral Squamous Cell Carcinoma Saliva Sample Group2 interventions
Group B: Non Oral Squamous Cell Carcinoma Saliva Sample Group2 interventions
Group C: Oral Squamous Cell Carcinoma Stool Sample Group2 interventions
Group D: Non Oral Squamous Cell Carcinoma Stool Sample Group2 interventions

Trial outcomes

Primary outcomes

1

Characterize human dysbiosis

Stool and saliva samples will be collected from participants, allowing us to reproduce human dysbiosis and analyze whether HNSCC affects one's microbiome composition. Metagenomic sequencing will be conducted through use of DNA extraction, library generation and Illumina sequencing. At least 30 million paired-end 2x150bp metagenomic reads will be generated per sample using the Illumina NovaSeq platform.

Time frame
Day 1
2

Characterize human metabolomics

Through our stool and saliva samples we will be able to characterize metagenomic and metabolic signatures in treatment naïve OSCC and non-OSCC patients. Metabolic analysis will be conducted using LC/MS-based metabolic analysis. A targeted approach will quantify a panel of 30 componds 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 and metabolic and immune statuses.

Time frame
Day 1
3

Integrative multi-omic data analysis and biomarker discovery

We expect to find that specific sets of microbial and host factors interact with each other to promote OSCC.

Time frame
Day 365

Secondary outcomes

1

Impact of human dysbiosis on OSCC development in mice

Freshly collected saliva and stool samples from 10 subjects of each treatment category will be used to reconstitute microbiota.

Time frame
Day 10-Day 100
2

Monitor tumor size

Tumor size (both weight and size) will be monitored using Bli-imaging. These measures will be assessed between treatment groups by ANOVA or analysis of variance testing.

Time frame
Day 10-Day 100

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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