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

NCT06861036 | Not Yet Recruiting

• 1 other identifier: ET22-338 HOASIS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Squamous Cell Carcinomas

Keywords

scRNAseq; Heterogeneity of all cell population; OSCC

Outcome Measures

Primary Outcomes (1)

• 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.

  Transcriptomic data from scRNAseq for all cell populations

  3 years

Secondary Outcomes (3)

• Description of the functional interactions among tumor, stromal, and immune subpopulations identified by scRNAseq

  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.

  3 years

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

  3 years

Study Arms (1)

Clinical-biological cohort

OTHER

A clinical-biological cohort of 50 patients with OSCC. Blood sample and biospecimen at the time of a standard surgery.

Procedure: Biospecimen; Procedure: Blood sampling

Interventions

Biospecimen PROCEDURE

* 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.

Clinical-biological cohort

Blood sampling PROCEDURE

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

Clinical-biological cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, 69008, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philippe Zrounba, M.D.

  philippe.zrounba@lyon.unicancer.fr

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Zrounba, M.D.

CONTACT

(0)4 69 85 60 82; philippe.zrounba@lyon.unicancer.fr

Karène Mahtouk, Ph.D.

CONTACT

04 69 85 60 82; karene.mahtouk@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 6, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: March 6, 2025

Record last verified: 2025-02

Locations

FR (1)