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

5 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

150

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: OSCC clinical-biological cohort
A clinical-biological cohort of 50 patients with OSCC. Blood sample and biospecimen at the time of a standard surgery.
Procedimiento: Muestreo de sangre
Muestreo de sangre (6 ml), tomado de un examen biológico de rutina.
Procedimiento: 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.
Procedimiento: Biospecimen
  • 1 OPMD lesion specimen.
  • 1 specimen of the healthy oral mucosa (facultative). The biospecimens will be collected during standard routine medical care.
Procedimiento: 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.).
Otro: OPMD clinical-biological cohort
A clinical-biological cohort of 50 patients with OPMD. Biospecimen at the time of a standard care.
Procedimiento: 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.
Procedimiento: Biospecimen
  • 1 OPMD lesion specimen.
  • 1 specimen of the healthy oral mucosa (facultative). The biospecimens will be collected during standard routine medical care.
Procedimiento: 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.).
Otro: 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.
Procedimiento: 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.
Procedimiento: Biospecimen
  • 1 OPMD lesion specimen.
  • 1 specimen of the healthy oral mucosa (facultative). The biospecimens will be collected during standard routine medical care.
Procedimiento: 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.).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Characterization of the heterogeneity of all cell populations (tumor cells, stromal and immune microenvironment) in OSCC and OPMD using scRNA-seq.
Periodo de tiempo: 4 years
Evaluation of transcriptomic data from all cell populations to define gene expression profiles and specific signatures.
4 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Description of the functional interactions among tumor, stromal, and immune subpopulations.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Centre Leon Berard

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de marzo de 2035

Finalización del estudio (Estimado)

1 de marzo de 2035

Fechas de registro del estudio

Enviado por primera vez

5 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de mayo de 2026

Publicado por primera vez (Actual)

12 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ET26-077 HOPES

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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