Clinical trial NCT06861036: Heterogeneity of Oral Squamous Cell Carcinoma Analysis by Single Cell RNA Sequencing
Official title: Heterogeneity of Oral Squamous Cell Carcinoma Analysis by Single Cell RNA Sequencing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oral Squamous Cell Carcinomas
Keywords: scRNAseq
Heterogeneity of all cell population
OSCC
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A clinical-biological cohort of patients with OSCC.

Samples:

* 1 blood sample (6 mL)
* 1 or 2 tumoral specimen (depending on the size of the tumor)
* 1 specimen of the healthy oral mucosa
* 1 leucoplakia specimen if applicable. The biospecimens will be collected at the time of the surgery scheduled in the standard routine medical care.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
measure: Description of the functional interactions among tumor, stromal, and immune subpopulations identified by scRNAseq
timeFrame: 3 years
measure: Correlation between refined patient stratification (based on tumor, stromal and immune sub-population) and the impact on the response to ex-vivo treatments.
timeFrame: 3 years
measure: Identification of prognostic and predictive biomarkers for oral squamous cell carcinoma evolution
timeFrame: 3 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: philippe.zrounba@lyon.unicancer.fr
name: Philippe Zrounba, M.D.
role: PRINCIPAL_INVESTIGATOR
References: