Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma

NCT07809100 — Not applicable, Not yet recruiting, 120 participants, Centre Hospitalier Sud Francilien

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Registry	NCT07809100, acronym MIC-VADS
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, basic science
Enrollment	120 (Estimated)
Sponsor	Centre Hospitalier Sud Francilien (Other)
Conditions	Squamous Cell Cancer of Head and Neck (SCCHN)
Interventions	Tissue and secretion sampling via biopsy (Diagnostic test, procedure)
Dates	start 2026-10-01 (estimated), primary completion 2027-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-09-09, last updated 2026-09-09
Locations	1 site in France

-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). 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Microbiome in head and neck squamous cell carcinoma Patients	Experimental	Diagnostic Test: Tissue and secretion sampling via biopsy; Procedure: Tissue and secretion sampling via biopsy	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

Tissue and secretion sampling via biopsy (Diagnostic 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 biopsy (Procedure): 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.

+Outcome measures

Primary outcomes

The difference in bacterial composition between the tumor, healthy mucosa, and hypopharyngeal secretions will be assessed [at day 1]

Secondary outcomes

Correlations between tumor microbiome diversity and composition and clinical/epidemiological data [at day 1]: tumor microbiome diversity (by sequencing) tumor microbiome composition (by sequencing)
Differences in the tumor microbiome between subgroups defined by tumor stage, histological type, or infiltration, using differentiation tests [at day 1]
Differential bacterial genera or strains between tumor, healthy, and pharyngeal microbiomes [at day 1]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
  * 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

+Locations (1)

Facility	City	Country	Status
Centre Hospitalier Sud Francilien	Corbeil-Essonnes, France	France

+Investigators

Béatrice SEGURENS, Study director, Phd, HDR