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Tumoral versus luminal microbiome in head and neck squamous cell carcinoma

NCT ID NCT07809100

NEW Sponsor: Centre Hospitalier Sud Francilien Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
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First seen Sep 09, 2026 · Last updated Sep 09, 2026

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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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Squamous cell cancer of head and neck (SCCHN)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, France, 91100, France

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