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Heterogeneity of Oral Carcinogenesis: From PrEneoplasia to Invasive Squamous Cell Carcinoma

ConditionsOral Squamous Cell CarcinomasOral Potentially Malignant Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Leon Berard

About this trial

The goal of this project is to characterise the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) present in the tumor and their normal (and OPMD) counterparts by scRNAseq in OSCC patients. Additionally, the study will evaluate the effectiveness of non-invasive cytobrushes as a diagnostic tool compared to traditional biopsies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

I1: Male or female at least 18 years old.

I2: For Cohort A: patients with OSCC who undergo surgery. For cohorts B and C: patients with OPMD.

I3: Patient who has agreed to participate in this research and sign consent.

I4: Patient affiliated to a medical insurance.

Disqualifiers

NI1: For cohorts B and C: Patient at high risk of bleeding, such as those receiving anticoagulant or antiplatelet therapy, those with coagulation disorders, or those with a history of severe bleeding within the two weeks prior to enrollment.

NI2: Pregnant or nursing woman.

NI3: Contraindication to general anesthesia.

NI4: Suspicion of rare tumor of particular histology other than squamous cell carcinoma (Sarcoma...).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen

    Procedure/Surgery

    * 1 or 2 tumoral specimen (depending on the size of the tumor). * 1 specimen of the healthy oral mucosa. * 1 OPMD specimen if applicable. The biospecimens will be collected at the time of the surgery organised for the standard routine medical care.

  • Blood sampling

    Procedure/Surgery

    Blood sampling (6 mL), taken from a routine biological exam.

  • Biospecimen

    Procedure/Surgery

    * 1 OPMD lesion specimen. * 1 specimen of the healthy oral mucosa (facultative). The biospecimens will be collected during standard routine medical care.

  • Biospecimen

    Procedure/Surgery

    * 1 cytobrush sample. * 1 OPMD lesion specimen. Samples must be collected in sequence (first the cytobrush, then the biopsy collected during standard routine medical care.).

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: OSCC clinical-biological cohortOther 2 interventions
Group B: OPMD clinical-biological cohortOther 1 intervention
Group C: Cyto-OPMD clinical-biological cohortOther 1 intervention

Trial outcomes

Primary outcomes

1

Characterization of the heterogeneity of all cell populations (tumor cells, stromal and immune microenvironment) in OSCC and OPMD using scRNA-seq.

Evaluation of transcriptomic data from all cell populations to define gene expression profiles and specific signatures.

Time frame
4 years

Secondary outcomes

1

Description of the functional interactions among tumor, stromal, and immune subpopulations.

Describe the functional interactions between tumor, stromal, and immune subpopulations identified by scRNA-seq and bulk RNA-seq using in vitro models and co-culture assays. Cellular responses will be assessed using transcriptomic analysis and phenotypic characterization.

Time frame
4 years
2

Correlation between refined patient stratification (based on tumor, stromal and immune sub-population) and the impact on the response to ex-vivo treatments.

Correlation between tumor, stromal and immune sub-populations likely to refine patient stratification and the impact on the response to ex-vivo treatments.

Time frame
4 years
3

Identification of prognostic and predictive biomarkers for oral squamous cell carcinoma evolution.

Correlation of gene expression profiles with disease progression to identify prognostic and predictive biomarkers in scRNAseq and bulk RNAseq datasets.

Time frame
4 years
4

Evaluation of cytobrushing as a non-invasive sampling method for diagnostic yield equivalence to tissue biopsy in OPMD patients.

Comparative assessment of cytobrushing and tissue biopsy to establish diagnostic equivalence and evaluate the reduction of clinical constraints in the sampling of OPMD lesions.

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Leon Berard

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: