Heterogeneity of Oral Squamous Cell Carcinoma Analysis by Single Cell RNA Sequencing

Not Applicable

Not yet recruiting

• Conditions: Oral Squamous Cell Carcinomas

• Registration Number: NCT06861036
• Lead Sponsor: Centre Leon Berard

Brief Summary

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 leucoplasic) counterparts by scRNAseq in OSCC patients.

Detailed Description

Epidermoid carcinomas of upper aerodigestive tract are the 8th most common cancers in the world. Worldwide, this represents more than 500.000 cases per year and 20.000 cases per year in France (statistics 2018-2020). Among these cancers, oral squamous cell carcinoma (OSCC) are the most common location, leading to significant morbidity and mortality.

OSCC treatment is based on surgery and/or radiotherapy and/or chemotherapy. Immune Check point Inhibitors (ICIs) targeting PD-1 have been approved for recurrent and metastasic OSCC. However, only 15-20% of these patients are treated thanks to this anti-PD-1. Thus, there is a real need to improve the efficacy of ICIs in the treatment of HNSCC. The scRNAseq is a method which allows to study the tumoral heterogeneity, the microenvironment and the dynamic and regulation mecanisms in cells cancer. This technology could improve patient stratification, identify pronostic biomarkers, constitute an important tool in the therapeutical take care and lead to understand tumoral evolution and develop new prevention strategies.

The aim of the study is to characterise the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) present in the tumor and their normal (and leucoplasic) counterparts by scRNAseq in OSCC patients.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Study Start: 2025-05-15
• Primary Completion: 2028-05-15
• Study Completion: 2028-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• I1. Male or female at least 18 years old.
• I2. Patient with OSCC and undergoing surgery at the Centre Léon Bérard.
• I3. Patient who has agreed to participate in this research and sign consent.
• I4. Patient affiliated to a medical insurance.

Exclusion Criteria

• NI1. Pregnant or nursing woman.
• NI2. Contraindication to general anesthesia.
• NI3. Suspicion of rare tumor of particular histology other than squamous cell carcinoma (Sarcoma...).
• NI4. Patient under curatorial or guardianship or placed under the protection of justice.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Characterization of the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) present in the tumor and their normal (and leucoplasic) counterparts by scRNAseq in OSCC patients.	3 years	Transcriptomic data from scRNAseq for all cell populations

Secondary Outcome Measures

Name	Time	Method
Description of the functional interactions among tumor, stromal, and immune subpopulations identified by scRNAseq	3 years	Describe the functional interactions between tumor, stromal, and immune subpopulations using ex vivo culture models and co-culture assays. Cellular responses will be assessed using transcriptomic analysis and phenotypic characterization.
Correlation between refined patient stratification (based on tumor, stromal and immune sub-population) and the impact on the response to ex-vivo treatments.	3 years	Correlation between tumor, stromal and immune sub-populations likely to refine patient stratification and the impact on the response to ex-vivo treatments.
Identification of prognostic and predictive biomarkers for oral squamous cell carcinoma evolution	3 years	Correlation of gene expression profiles with disease progression to identify prognostic and predictive biomarkers in scRNAseq and bulk RNAseq datasets

Trial Locations

Locations (1)

Centre Léon Bérard; 🇫🇷 Lyon, France