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Not yet recruiting NCT06861036

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

No phase Interventional Oral Squamous Cell Carcinomas

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen, Blood sampling.
Who it may be relevant to
Registry conditions: Oral Squamous Cell Carcinomas. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Procedure Biospecimen
    * 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 organised for the standard routine medical care.
  • Procedure Blood sampling
    Blood sampling (6 mL), taken from a routine biological exam.

Primary outcome measures

  • 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. [Time frame: 3 years]
Secondary outcome measures (3)
  • Description of the functional interactions among tumor, stromal, and immune subpopulations identified by scRNAseq [Time frame: 3 years]
  • Correlation between refined patient stratification (based on tumor, stromal and immune sub-population) and the impact on the response to ex-vivo treatments. [Time frame: 3 years]
  • Identification of prognostic and predictive biomarkers for oral squamous cell carcinoma evolution [Time frame: 3 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Centre Léon Bérard — Lyon

Identifiers

NCT: NCT06861036 · ET22-338 HOASIS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗