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

5 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

150

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 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: Bloedproef
Bloedbemonstering (6 ml), afkomstig van een routinematig biologisch examen.
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.).
Ander: 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.).
Ander: 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.).

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Description of the functional interactions among tumor, stromal, and immune subpopulations.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Centre Leon Berard

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 maart 2035

Studie voltooiing (Geschat)

1 maart 2035

Studieregistratiedata

Eerst ingediend

5 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 mei 2026

Eerst geplaatst (Werkelijk)

12 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

5 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ET26-077 HOPES

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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