- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07664891
Metabolic Reprogramming and Microenvironment in Pancreatic Adenocarcinoma
Metabolic Reprogramming and Microenvironment in Pancreatic Adenocarcinoma: Identification of New Therapeutic Targets
The present project aims to elucidate the metabolic interactions within the tumor microenvironment of pancreatic adenocarcinoma, both in the primary tumor and in hepatic and pulmonary metastatic sites, as well as in circulating blood biomarkers.
Deciphering these complex interactions aims to identify exploitable vulnerabilities for predicting treatment efficacy or for guiding therapeutic strategies.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Pancreatic adenocarcinoma (PDAC) remains one of the deadliest cancers, with survival rarely exceeding a few months and limited progress despite improved chemotherapy. Its poor prognosis is driven by late diagnosis, therapeutic resistance, and low responsiveness to targeted therapies and immunotherapy.
PDAC is characterized by a dense, immunosuppressive stroma and severe metabolic stress due to poor vascularization. Tumor progression relies heavily on stromal cells-such as cancer-associated fibroblasts and macrophages-as well as metabolic adaptations of cancer cells.
This project focuses on two key PDAC features to identify new biomarkers and therapeutic targets:
- Stromal cell prevalence
- Metabolic reprogramming
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jihane PAKRADOUNI
- Número de teléfono: +334 91223778
- Correo electrónico: drci.up@ipc-unicancer.fr
Ubicaciones de estudio
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Marseille, Francia, 13009
- Reclutamiento
- Institut Paoli-Calmettes
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Contacto:
- Jihane PAKRADOUNI
- Número de teléfono: +334 91223778
- Correo electrónico: drci.up@ipc.unicancer.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age > 18 years
- Signed written informed consent specific to the PROMETAP study
- Affiliation with a social security system
- Treatment and follow-up performed at the Institut Paoli-Calmettes
- Metastatic PDAC requiring biopsy as part of routine care (group1 and 2)
Prior treatment:
- No previous chemotherapy for the "initial" group
- No prior chemotherapy in the metastatic setting for the "Metastatic Relapse" group
- Eligible for chemotherapy (ECOG < 2)
Non-Inclusion Criteria:
- Contraindication to biopsy of the pancreatic tumor or a hepatic or pulmonary metastasis (group 1 and 2)
- Absence of a metastasis accessible to biopsy (group1 and 2)
- Concurrent treatment for another active cancer
- Pregnant or breastfeeding women
- Patients in emergency situations
5. Adult individuals under legal protection (guardianship, trusteeship, judicial protection) or unable to provide informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Groupe 1-Initial
Paired pancreatic and liver/lung metastatic biopsies will be used to establish primary and metastatic cell cultures from tumor specimens obtained during routine diagnostic procedures, along with peripheral blood samples, in a cohort of 12 patients
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Tumor cells isolation
Isolation of blood monocytes
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Group 2- Relapse
Biopsies of liver or lung metastases obtained at metastatic relapse or progression, along with peripheral blood samples, will be required from 12 patients for the establishment of primary and metastatic cell cultures.
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Tumor cells isolation
Isolation of blood monocytes
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Group 3- Biological
40 patient samples collected before chemotherapy and paired samples collected during chemotherapy will support molecular and cellular analyses aimed at identifying and assessing novel biomarkers and therapeutic strategies
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Isolation of blood monocytes
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluation and comparison of biological parameters reflecting metabolic alterations within the tumor microenvironment of pancreatic adenocarcinoma
Periodo de tiempo: From sample collection to completion of analyses, estimated at 3 years
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These analyses aim to identify potential therapeutic targets and to explore diagnostic, prognostic, and predictive biomarkers of treatment response. |
From sample collection to completion of analyses, estimated at 3 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Exploratory characterization of metabolic pathways, tumor microenvironment features, and associated biomarkers in pancreatic adenocarcinoma.
Periodo de tiempo: From sample collection to completion of analyses, estimated at 3 years
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From sample collection to completion of analyses, estimated at 3 years
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PROMETAP-IPC 2022-048
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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