Head and Neck CancerNCT05837221
Microbiome in Head and Neck Squamous Cell Carcinoma
An observational study of Head and Neck Cancer and Lip Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Head and Neck Cancer, Lip Cancer, Oral Cancer
- What is being tested?
- Metagenomic sequencing and Metabolic analysis
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2025to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
- Ability to understand and willingness to sign a written informed consent document
Who cannot join
- Subjects under the age of 18 or over the age of 100
- Subjects unwilling to particiapte
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Cancer Center
Aurora, Colorado, 80045
Yosr Doghri, (303) 724-6550, yosr.doghri@cuanschutz.edu
Shi-Long Lu, MD, PhD
About this study
Official title: Role of Human Microbiome in Head and Neck Cancer
This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.
Read the 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
- Being tested
- Metagenomic sequencing, Metabolic analysis
- Medical subject headings
- Head and Neck Neoplasms, Lip Neoplasms, Mouth Neoplasms, Pharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metagenomic sequencingDiagnostic 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 analysisDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Metagenomic sequencing; Diagnostic Test: Metabolic analysis | |
| 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. Receives: Diagnostic Test: Metagenomic sequencing; Diagnostic Test: Metabolic analysis | |
| 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.). Receives: Diagnostic Test: Metagenomic sequencing; Diagnostic Test: Metabolic analysis | |
| 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.). Receives: Diagnostic Test: Metagenomic sequencing; Diagnostic Test: Metabolic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 365
Secondary outcomes (2)
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.
Measured: Day 10-Day 100
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.
Measured: Day 10-Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start23 May 2025
- Primary completionNov 2026 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shi-Long E Lu, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837221
- Sponsor's protocol ID
- 23-0016.cc
- Other IDs
- P50CA261605
- Status last verified
- Feb 2026
- First submitted
- 19 Apr 2023
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Human Microbiome in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05837221
- Acronym / sponsor ID
- 23-0016.cc
- Conditions
- Head and Neck Cancer, Lip Cancer, Oral Cancer, Pharynx Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 May 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral Squamous Cell Carcinoma Saliva Sample Group | – | Diagnostic Test: Metagenomic sequencing, Diagnostic Test: Metabolic analysisSaliva 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. |
| Non Oral Squamous Cell Carcinoma Saliva Sample Group | – | Diagnostic Test: Metagenomic sequencing, Diagnostic Test: Metabolic analysisSaliva 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. |
| Oral Squamous Cell Carcinoma Stool Sample Group | – | Diagnostic Test: Metagenomic sequencing, Diagnostic Test: Metabolic analysisStool 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.). |
| Non Oral Squamous Cell Carcinoma Stool Sample Group | – | Diagnostic Test: Metagenomic sequencing, Diagnostic Test: Metabolic analysisStool 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.). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
- Ability to understand and willingness to sign a written informed consent document
Key exclusion criteria (2 listed)
- Subjects under the age of 18 or over the age of 100
- Subjects unwilling to particiapte
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metagenomic sequencingShotgun 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. | Diagnostic test | Non Oral Squamous Cell Carcinoma Saliva Sample Group, Non Oral Squamous Cell Carcinoma Stool Sample Group, Oral Squamous Cell Carcinoma Saliva Sample Group, Oral Squamous Cell Carcinoma Stool Sample Group |
| Metabolic analysisMetabolic 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 | Diagnostic test | Non Oral Squamous Cell Carcinoma Saliva Sample Group, Non Oral Squamous Cell Carcinoma Stool Sample Group, Oral Squamous Cell Carcinoma Saliva Sample Group, Oral Squamous Cell Carcinoma Stool Sample Group |
Primary outcome
Characterize human dysbiosis
Time frame: Day 1
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.
Characterize human metabolomics
Time frame: Day 1
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.
Integrative multi-omic data analysis and biomarker discovery
Time frame: Day 365
We expect to find that specific sets of microbial and host factors interact with each other to promote OSCC.
2 secondary outcomes
Impact of human dysbiosis on OSCC development in mice
Time frame: Day 10-Day 100
Monitor tumor size
Time frame: Day 10-Day 100
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shi-Long E Lu, MD, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Lip Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yosr Doghri ((303) 724-6550, yosr.doghri@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize human dysbiosis (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.