Heterogeneity of Oral Squamous Cell Carcinoma Analysis by Single Cell RNA Sequencing (HOASIS)

February 28, 2025 updated by: Centre Leon Berard
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Clinical-biological cohort

A clinical-biological cohort of 50 patients with OSCC.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Transcriptomic data from scRNAseq for all cell populations
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the functional interactions among tumor, stromal, and immune subpopulations identified by scRNAseq
Time Frame: 3 years
Describe 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.
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
Correlation between tumor, stromal and immune sub-populations likely to refine patient stratification and the impact on the response to ex-vivo treatments.
3 years
Identification of prognostic and predictive biomarkers for oral squamous cell carcinoma evolution
Time Frame: 3 years
Correlation of gene expression profiles with disease progression to identify prognostic and predictive biomarkers in scRNAseq and bulk RNAseq datasets
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Investigators

  • Principal Investigator: Philippe Zrounba, M.D., philippe.zrounba@lyon.unicancer.fr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2025

Primary Completion (Estimated)

May 15, 2028

Study Completion (Estimated)

May 15, 2028

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ET22-338 HOASIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oral Squamous Cell Carcinomas

Clinical Trials on Biospecimen

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe