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

NCT ID: NCT06861036

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2028-05-15

Brief Summary

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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

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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.

Conditions

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Oral Squamous Cell Carcinomas

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Clinical-biological cohort

A clinical-biological cohort of 50 patients with OSCC.

Blood sample and biospecimen at the time of a standard surgery.

Group Type OTHER

Biospecimen

Intervention Type 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.

Blood sampling

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Blood sampling

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Leon Berard

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Zrounba, M.D.

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Centre Léon Bérard

Lyon, , France

Site Status

Countries

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France

Central Contacts

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Philippe Zrounba, M.D.

Role: CONTACT

(0)4 69 85 60 82 ext. +33

Karène Mahtouk, Ph.D.

Role: CONTACT

04 69 85 60 82 ext. +33

Facility Contacts

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Philippe Zrounba, M.D.

Role: primary

Other Identifiers

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ET22-338 HOASIS

Identifier Type: -

Identifier Source: org_study_id

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