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ONCOGRAMStudy of the Therapeutic Response and Survival of Patients with Metastatic Colorectal Cancer (stage IV) and Treated According to the Guidelines of a Chemosensitivity Test, Oncogramme®

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Qué se está evaluando

Oncogramme®

Otro
Quiénes están siendo reclutados

A partir de 18 años
+13 Criterios de eligibilidad
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Cómo está diseñado el estudio

Otro tipo de estudio

Intervencional
Inicio del estudio: julio de 2017
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity Hospital, Limoges
Última actualización: 28 de enero de 2026
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Fecha de inicio: 24 de julio de 2017

Fecha en la que se inscribió al primer participante.

Currently, chemotherapies are empirically administered to patients treated for colorectal cancer (CRC). Selection is based on the efficacy of a protocol previously determined on the largest number (consensus treatment), the decision-making process being weighted by patient's intrinsic criteria. However, each patient is unique, due to the inter- and intratumoral heterogeneity inherent in any cancer, partly explaining the unsatisfactory response rates observed for available chemotherapies. Functional sensitivity tests offer the possibility to adapt the treatment to each patient: they are based on an ex vivo study of the responses of the tumor cells (survival / death) to the different molecules / therapeutic combinations (chemotherapy or targeted therapy) likely to be administered to the patient. This response, translated into a tumor-specific sensitivity profile, can be used by the clinicians to determine the most appropriate therapeutic protocol. By increasing the therapeutic efficacy from the first line and reducing the deleterious side effects associated with multiple drug cycles, the sensitivity test transforms the consensus approach into personalized medicine, providing patients with improved progression free survival (PFS) associated with an improvement in the quality of life. Oncomedics has developed Oncogramme®, a CE-labeled in vitro diagnostic medical device that has already demonstrated the ability to predict chemosensitivity in a recent pilot study of metastatic CRC (prediction with 84% chance of success of tumor sensitivity to chemotherapy, vs. 50% maximum for chemotherapy administered according to the consensus method). The hypothesis that patients treated with a metastatic CRC for which systemic chemotherapy is adapted using Oncogramme® have better response rates, PFS and quality of life than patients treated according to usual practice, with optimization of the costs of care. To our knowledge, this is the only fully standardized test available, where each step and reagents of the procedure are mastered. The reliability of the procedure makes it possible to render a personalized result for each patient in 97% of the cases. In addition, the analysis is specifically centered on tumor cells using a method using fully defined, developed and validated media and reagents for each cancer, including CRC. The method of revealing the effect of the therapies identifies the proportion of dead cells in each condition, whatever their physiological state (proliferation / quiescence), by determining the percentage of living and killed cells, thus ensuring high sensitivity

Título OficialStudy of the Therapeutic Response and Survival of Patients with Metastatic Colorectal Cancer (stage IV) and Treated According to the Guidelines of a Chemosensitivity Test, Oncogramme®
NCT03133273
Patrocinador PrincipalUniversity Hospital, Limoges
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 256 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Otro Tipo de Estudio

Algunos estudios exploran temas que no encajan en una categoría específica. Pueden incluir investigaciones innovadoras, nuevas tecnologías o áreas emergentes en el ámbito de la salud.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Criterios

7 criterios de inclusión requeridos para participar
Age ≥ 18 years

Patient with metastatic colon or rectal adenocarcinoma (Stage IV) who can benefit from standard systemic chemotherapy (monotherapy based on 5-FU, polychemotherapy type FOLFOX, FOLFIRI, FOLFIRINOX, associated or not with targeted therapies Adapted to the expression of BRAF and RAS, whatever the route of administration of the proposed, oral or intravenous therapies)

Metastatic CRC diagnosed preoperatively on imaging or per-operative on macroscopic findings and proved by histological analysis (biopsy or surgical excision and if possible biopsies or excrescence on the metastatic sites)

Measurable metastases according to RECIST

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6 criterios de exclusión impiden participar
Formal contraindication to paraclinic exploration essential for patient follow-up

Exclusive use of radiotherapy, targeted therapy, immunotherapy or hormone therapy, exclusive palliative support

Patient with an absolute contraindication to the administration of chemotherapy

Pregnant, lactating or non-contraceptive women for childbearing age women

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
For patients in the Oncogramme® group, chemotherapy will be adapted to Oncogramme® results.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 13 ubicaciones

Suspendido

CHU d'AMIENS

Amiens, FranceAbrir CHU d'AMIENS en Google Maps
Suspendido

Bergonié Institut

Bordeaux, France
Suspendido

Clinique des Cédres

Brive-la-Gaillarde, France
Suspendido

CHU de TOURS

Chambray-lès-Tours, France
Completado13 Centros de Estudio