Squamous Cell Cancer of Head and Neck (SCCHN)MIC-VADSNCT07809100
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
A study testing Tissue and secretion sampling via biopsy in people with Squamous Cell Cancer of Head and Neck (SCCHN), run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
Head and neck squamous cell carcinoma (HNSCC), France's 5th most common cancer (15,000 annual cases), presents significant public health challenges due to high morbidity and functional/aesthetic sequelae from treatments (mutilating surgery, radiotherapy, chemotherapy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Cancer of Head and Neck (SCCHN)
- What is being tested?
- Tissue and secretion sampling via biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient
- Consultation in the ENT department for suspected squamous cell carcinoma of the upper aerodigestive tract scheduled for panendoscopy
- Patient has provided consent to participate in the study and signed an informed consent form
Who cannot join
- Antibiotic or corticosteroid therapy within 12 weeks prior to consultation
- Conditions associated with immunosuppression:
- Uncontrolled HIV infection (CD4 < 200 cells/µL) (permanent exclusion)
- Hematologic malignancies currently under treatment or not in complete remission for <2 years
- Autoimmune diseases under immunosuppressive treatment
- Solid organ or stem cell transplant recipients (permanent exclusion)
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- Poorly controlled diabetes (HbA1c > 9%)
- Immunomodulatory treatment within 3 months prior to consultation:
- Immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1, anti-CTLA-4)
- Biotherapy targeting the immune system (anti-TNF, anti-IL, calcineurin inhibitors, antimetabolites)
- Recurrent upper aerodigestive tract cancer previously treated with surgery and/or radiochemotherapy
- Pregnancy (confirmed prior to panendoscopy)
- Patient who does not speak or understand French
- Subject under guardianship or curatorship
- Subject not affiliated with the national health insurance system
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91100
Renato TORRES, MD, 01 61 69 34 59 ext. +33, renato.torres-lazo@chsf.fr
Renato TORRES, MD
About this study
Head and neck squamous cell carcinoma (HNSCC), France's 5th most common cancer (15,000 annual cases), presents significant public health challenges due to high morbidity and functional/aesthetic sequelae from treatments (mutilating surgery, radiotherapy, chemotherapy). Major risk factors, tobacco and alcohol, create a chronic inflammatory environment promoting tumor development. The upper aerodigestive tract microbiome, influenced by these exposures and local alterations (necrosis, bleeding, ulcerations), is emerging as a potential factor in tumor progression, severity biomarker, or therapeutic target, though its exact role (cause or consequence) remains to be elucidated
Objectives:
Read more
- Primary: Compare bacterial microbiome composition between tumor tissue, adjacent healthy mucosa, and pharyngeal secretions
- Secondary:
- Correlate microbiome diversity/composition with clinical and epidemiological characteristics
- Identify microbiome variations by tumor stage, histology, and infiltration
- Discover diagnostic/prognostic microbial markers
- Analyze somatic variants (SNP/CNV) via whole-genome sequencing (WGS) and their association with microbiome profiles and clinical parameters
Study Design: Prospective, cross-sectional study with paired design (each patient serves as their own control to minimize genetic variation biases)
Methods:
- Samples: Tumor, adjacent healthy tissue, and pharyngeal secretions (3 samples/patient)
- Sequencing: Metagenomic sequencing (complete bacterial genomes) when biomass permits, or targeted 16S rRNA sequencing to identify dominant genera.
- Pilot study: 20 patients to select the optimal technique and validate feasibility, particularly assessing DNA quantity in these low-biomass environments
Population: Adults with suspected HNSCC scheduled for panendoscopy
Exclusion criteria: Recent antibiotics/corticosteroids (12 weeks), immunosuppression (uncontrolled HIV, active hematologic malignancies, autoimmune diseases on immunosuppressants, organ/stem cell transplants, uncontrolled diabetes), immunomodulatory treatments (3 months), recurrence, pregnancy, non-French speakers, legal guardianship, or lack of social security.
Safety: No additional risks beyond standard panendoscopy.
Expected impact: This approach may pave the way for innovative diagnostic or therapeutic strategies based on microbiome modulation in HNSCC.
- Being tested
- Tissue and secretion sampling via biopsy
- Keywords
- microbiota, SCCHN, metagenomics, RNA, ribosomal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue and secretion sampling via biopsyDiagnostic test
Additional biopsies (beyond standard clinical practice) taken during panendoscopy to collect:
- Tumor tissue
- Adjacent healthy mucosa
- Pharyngeal secretions
These samples are used for microbiome analysis.
head and neck squamous cell carcinoma Note: The panendoscopy itself is a standard clinical procedure, but the additional biopsies for research purposes represent the study-specific intervention.
Tissue and secretion sampling via biopsyProcedure or surgery
Additional biopsies (beyond standard clinical practice) taken during panendoscopy to collect:
- Tumor tissue
- Adjacent healthy mucosa
- Pharyngeal secretions
These samples are used for microbiome analysis.
head and neck squamous cell carcinoma Note: The panendoscopy itself is a standard clinical procedure, but the additional biopsies for research purposes represent the study-specific intervention.
| Study group | Role | What they receive |
|---|---|---|
| Microbiome in head and neck squamous cell carcinoma Patients | Experimental | Patients with suspected head and neck squamous cell carcinoma undergoing panendoscopy with additional biopsy sampling of tumor tissue, adjacent healthy mucosa, and pharyngeal secretions for microbiome analysis Receives: Diagnostic Test: Tissue and secretion sampling via biopsy; Procedure: Tissue and secretion sampling via biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in bacterial composition between the tumor, healthy mucosa, and hypopharyngeal secretions will be assessed
Measured: at day 1
Secondary outcomes (3)
Correlations between tumor microbiome diversity and composition and clinical/epidemiological data
tumor microbiome diversity (by sequencing) tumor microbiome composition (by sequencing)
Measured: at day 1
Differences in the tumor microbiome between subgroups defined by tumor stage, histological type, or infiltration, using differentiation tests
Measured: at day 1
Differential bacterial genera or strains between tumor, healthy, and pharyngeal microbiomes
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Cancer of Head and Neck (SCCHN)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Béatrice SEGURENS, Study director, Phd, HDR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809100
- Sponsor's protocol ID
- 2026-A00392-49
- Other IDs
- 2026/0003
- Acronym
- MIC-VADS
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07809100
- Acronym / sponsor ID
- MIC-VADS / 2026-A00392-49
- Keywords
- microbiota, SCCHN, metagenomics, RNA, ribosomal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Sep 2026 (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.
Head and neck squamous cell carcinoma (HNSCC), France's 5th most common cancer (15,000 annual cases), presents significant public health challenges due to high morbidity and functional/aesthetic sequelae from treatments (mutilating surgery, radiotherapy, chemotherapy). Major risk factors, tobacco and alcohol, create a chronic inflammatory environment promoting tumor development. The upper aerodigestive tract microbiome, influenced by these exposures and local alterations (necrosis, bleeding, ulcerations), is emerging as a potential factor in tumor progression, severity biomarker, or therapeutic target, though its exact role (cause or consequence) remains to be elucidated
Objectives:
- Primary: Compare bacterial microbiome composition between tumor tissue, adjacent healthy mucosa, and pharyngeal secretions
- Secondary:
- Correlate microbiome diversity/composition with clinical and epidemiological characteristics
- Identify microbiome variations by tumor stage, histology, and infiltration
- Discover diagnostic/prognostic microbial markers
- Analyze somatic variants (SNP/CNV) via whole-genome sequencing (WGS) and their association with microbiome profiles and clinical parameters
Study Design: Prospective, cross-sectional study with paired design (each patient serves as their own control to minimize genetic variation biases)
Methods:
- Samples: Tumor, adjacent healthy tissue, and pharyngeal secretions (3 samples/patient)
- Sequencing: Metagenomic sequencing (complete bacterial genomes) when biomass permits, or targeted 16S rRNA sequencing to identify dominant genera.
- Pilot study: 20 patients to select the optimal technique and validate feasibility, particularly assessing DNA quantity in these low-biomass environments
Population: Adults with suspected HNSCC scheduled for panendoscopy
Exclusion criteria: Recent antibiotics/corticosteroids (12 weeks), immunosuppression (uncontrolled HIV, active hematologic malignancies, autoimmune diseases on immunosuppressants, organ/stem cell transplants, uncontrolled diabetes), immunomodulatory treatments (3 months), recurrence, pregnancy, non-French speakers, legal guardianship, or lack of social security.
Safety: No additional risks beyond standard panendoscopy.
Expected impact: This approach may pave the way for innovative diagnostic or therapeutic strategies based on microbiome modulation in HNSCC.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microbiome in head and neck squamous cell carcinoma Patients | Experimental | Diagnostic Test: Tissue and secretion sampling via biopsy, Procedure: Tissue and secretion sampling via biopsyPatients with suspected head and neck squamous cell carcinoma undergoing panendoscopy with additional biopsy sampling of tumor tissue, adjacent healthy mucosa, and pharyngeal secretions for microbiome analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient
- Consultation in the ENT department for suspected squamous cell carcinoma of the upper aerodigestive tract scheduled for panendoscopy
- Patient has provided consent to participate in the study and signed an informed consent form
Key exclusion criteria (15 listed)
- Antibiotic or corticosteroid therapy within 12 weeks prior to consultation
- Conditions associated with immunosuppression:
- Immunomodulatory treatment within 3 months prior to consultation:
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 |
|---|---|---|
| Tissue and secretion sampling via biopsyAdditional biopsies (beyond standard clinical practice) taken during panendoscopy to collect: * Tumor tissue * Adjacent healthy mucosa * Pharyngeal secretions These samples are used for microbiome analysis. head and neck squamous cell carcinoma Note: The panendoscopy itself is a standard clinical procedure, but the additional biopsies for research purposes represent the study-specific intervention. | Diagnostic test | Microbiome in head and neck squamous cell carcinoma Patients |
| Tissue and secretion sampling via biopsyAdditional biopsies (beyond standard clinical practice) taken during panendoscopy to collect: * Tumor tissue * Adjacent healthy mucosa * Pharyngeal secretions These samples are used for microbiome analysis. head and neck squamous cell carcinoma Note: The panendoscopy itself is a standard clinical procedure, but the additional biopsies for research purposes represent the study-specific intervention. | Procedure or surgery | Microbiome in head and neck squamous cell carcinoma Patients |
Primary outcome
The difference in bacterial composition between the tumor, healthy mucosa, and hypopharyngeal secretions will be assessed
Time frame: at day 1
3 secondary outcomes
Correlations between tumor microbiome diversity and composition and clinical/epidemiological data
Time frame: at day 1
Differences in the tumor microbiome between subgroups defined by tumor stage, histological type, or infiltration, using differentiation tests
Time frame: at day 1
Differential bacterial genera or strains between tumor, healthy, and pharyngeal microbiomes
Time frame: at day 1
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 9 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Béatrice SEGURENS study director
Phd, HDR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue and secretion sampling via biopsy in people with Squamous Cell Cancer of Head and Neck (SCCHN), run by Centre Hospitalier Sud Francilien at 1 site in France.
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 3 inclusion and 15 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: opening soon, as of the sponsor's last update on 9 Sep 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 France. 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 Renato TORRES, MD (01 61 69 34 59 ext. +33, renato.torres-lazo@chsf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in bacterial composition between the tumor, healthy mucosa, and hypopharyngeal secretions will be assessed (time frame: at day 1). 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 9 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.