Heterogeneity of Oral Carcinogenesis: From PrEneoplasia to Invasive Squamous Cell Carcinoma (HOPES)

May 5, 2026 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 OPMD) counterparts by scRNAseq in OSCC patients. Additionally, the study will evaluate the effectiveness of non-invasive cytobrushes as a diagnostic tool compared to traditional biopsies.

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 project is organized into three cohorts:

  • Cohort A (OSCC): Designed to compare malignant cells directly with their healthy and pre-malignant counterparts within the same patient.
  • Cohort B (OPMD): Focused on patients with potentially malignant lesions but no active cancer.
  • Cohort C (Cyto-OPMD): Validating a non-invasive sampling method. The goal is to determine if a cytobrush can provide the same high-quality genomic data as a biopsy.

By combining these approaches, the project aims to characterize the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) to improve the global management of patients.

Study Type

Interventional

Enrollment (Estimated)

150

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: For Cohort A: patients with OSCC who undergo surgery. For cohorts B and C: patients with OPMD.
  • I3: Patient who has agreed to participate in this research and sign consent.
  • I4: Patient affiliated to a medical insurance.
  • I5: Patient who have not previously received any anticancer treatment (radiotherapy, chemotherapy, or immunotherapy)

Exclusion Criteria:

  • NI1: For cohorts B and C: Patient at high risk of bleeding, such as those receiving anticoagulant or antiplatelet therapy, those with coagulation disorders, or those with a history of severe bleeding within the two weeks prior to enrollment.
  • NI2: Pregnant or nursing woman.
  • NI3: Contraindication to general anesthesia.
  • NI4: Suspicion of rare tumor of particular histology other than squamous cell carcinoma (Sarcoma...).
  • NI5: 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: OSCC clinical-biological cohort
A clinical-biological cohort of 50 patients with OSCC. Blood sample and biospecimen at the time of a standard surgery.
Procedure: Blood sampling
Blood sampling (6 mL), taken from a routine biological exam.
Procedure: Biospecimen
  • 1 or 2 tumoral specimen (depending on the size of the tumor).
  • 1 specimen of the healthy oral mucosa.
  • 1 OPMD specimen if applicable. The biospecimens will be collected at the time of the surgery organised for the standard routine medical care.
Procedure: Biospecimen
  • 1 OPMD lesion specimen.
  • 1 specimen of the healthy oral mucosa (facultative). The biospecimens will be collected during standard routine medical care.
Procedure: Biospecimen
  • 1 cytobrush sample.
  • 1 OPMD lesion specimen. Samples must be collected in sequence (first the cytobrush, then the biopsy collected during standard routine medical care.).
Other: OPMD clinical-biological cohort
A clinical-biological cohort of 50 patients with OPMD. Biospecimen at the time of a standard care.
Procedure: Biospecimen
  • 1 or 2 tumoral specimen (depending on the size of the tumor).
  • 1 specimen of the healthy oral mucosa.
  • 1 OPMD specimen if applicable. The biospecimens will be collected at the time of the surgery organised for the standard routine medical care.
Procedure: Biospecimen
  • 1 OPMD lesion specimen.
  • 1 specimen of the healthy oral mucosa (facultative). The biospecimens will be collected during standard routine medical care.
Procedure: Biospecimen
  • 1 cytobrush sample.
  • 1 OPMD lesion specimen. Samples must be collected in sequence (first the cytobrush, then the biopsy collected during standard routine medical care.).
Other: Cyto-OPMD clinical-biological cohort
A clinical-biological cohort of 50 patients with OPMD (Cyto-OPMD). Biospecimen via cytobrush and biopsy at the time of a standard care.
Procedure: Biospecimen
  • 1 or 2 tumoral specimen (depending on the size of the tumor).
  • 1 specimen of the healthy oral mucosa.
  • 1 OPMD specimen if applicable. The biospecimens will be collected at the time of the surgery organised for the standard routine medical care.
Procedure: Biospecimen
  • 1 OPMD lesion specimen.
  • 1 specimen of the healthy oral mucosa (facultative). The biospecimens will be collected during standard routine medical care.
Procedure: Biospecimen
  • 1 cytobrush sample.
  • 1 OPMD lesion specimen. Samples must be collected in sequence (first the cytobrush, then the biopsy collected during standard routine medical care.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of the heterogeneity of all cell populations (tumor cells, stromal and immune microenvironment) in OSCC and OPMD using scRNA-seq.
Time Frame: 4 years
Evaluation of transcriptomic data from all cell populations to define gene expression profiles and specific signatures.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the functional interactions among tumor, stromal, and immune subpopulations.
Time Frame: 4 years
Describe the functional interactions between tumor, stromal, and immune subpopulations identified by scRNA-seq and bulk RNA-seq using in vitro models and co-culture assays. Cellular responses will be assessed using transcriptomic analysis and phenotypic characterization.
4 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: 4 years
Correlation between tumor, stromal and immune sub-populations likely to refine patient stratification and the impact on the response to ex-vivo treatments.
4 years
Identification of prognostic and predictive biomarkers for oral squamous cell carcinoma evolution.
Time Frame: 4 years
Correlation of gene expression profiles with disease progression to identify prognostic and predictive biomarkers in scRNAseq and bulk RNAseq datasets.
4 years
Evaluation of cytobrushing as a non-invasive sampling method for diagnostic yield equivalence to tissue biopsy in OPMD patients.
Time Frame: 4 years
Comparative assessment of cytobrushing and tissue biopsy to establish diagnostic equivalence and evaluate the reduction of clinical constraints in the sampling of OPMD lesions.
4 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)

June 1, 2026

Primary Completion (Estimated)

March 1, 2035

Study Completion (Estimated)

March 1, 2035

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ET26-077 HOPES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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