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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06861036
Acronym
HOASIS
Enrollment
50
Registered
2025-03-06
Start date
2025-05-15
Completion date
2028-05-15
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Squamous Cell Carcinomas

Keywords

scRNAseq, Heterogeneity of all cell population, OSCC

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.

Interventions

PROCEDUREBiospecimen

* 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.

PROCEDUREBlood sampling

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

Sponsors

Centre Leon Berard
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 yearsTranscriptomic data from scRNAseq for all cell populations

Secondary

MeasureTime frameDescription
Description of the functional interactions among tumor, stromal, and immune subpopulations identified by scRNAseq3 yearsDescribe 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 yearsCorrelation 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 evolution3 yearsCorrelation of gene expression profiles with disease progression to identify prognostic and predictive biomarkers in scRNAseq and bulk RNAseq datasets

Countries

France

Contacts

Primary ContactPhilippe Zrounba, M.D.
philippe.zrounba@lyon.unicancer.fr(0)4 69 85 60 82
Backup ContactKarène Mahtouk, Ph.D.
karene.mahtouk@lyon.unicancer.fr04 69 85 60 82

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026