NCT07809100

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Dec 2027

First Submitted

Initial submission to the registry

August 28, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

August 28, 2026

Last Update Submit

September 7, 2026

Conditions

Squamous Cell Cancer of Head and Neck (SCCHN)

Keywords

microbiotaSCCHNmetagenomicsRNAribosomal

Outcome Measures

Primary Outcomes (1)

  • The difference in bacterial composition between the tumor, healthy mucosa, and hypopharyngeal secretions will be assessed

    at day 1

Secondary Outcomes (3)

  • Correlations between tumor microbiome diversity and composition and clinical/epidemiological data

    at day 1

  • 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

Study Arms (1)

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

Diagnostic Test: Tissue and secretion sampling via biopsyProcedure: Tissue and secretion sampling via biopsy

Interventions

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.

Microbiome in head and neck squamous cell carcinoma Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Antibiotic or corticosteroid therapy within 12 weeks prior to consultation
  • Conditions associated with immunosuppression:
  • Hematologic malignancies currently under treatment or not in complete remission for \<2 years
  • Autoimmune diseases under immunosuppressive treatment
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91100, France

Location

MeSH Terms

Interventions

Histocompatibility Testing

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • BĂ©atrice SEGURENS

    Phd, HDR

    STUDY DIRECTOR

Central Study Contacts

Renato TORRES, MD

CONTACT

01 61 69 34 59renato.torres-lazo@chsf.fr

Caroline TOURTE

CONTACT

01 61 69 31 50caroline.tourte@chsf.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2026

First Posted

September 9, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)