- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01904916
CPCT-05 Biopsy Protocol Patient Selection
Protocol to Obtain Tumor Biopsies From Patients With Locally Advanced (Incurable) or Metastatic Cancer to Improve Selection for Clinical Trials. (CPCT - 05 Biopsy Protocol Patient Selection)
Our knowledge on the genetic mutations in cancer is rapidly expanding and we are increasingly testing drugs in mainly metastatic cancer patient populations with rare mutations. Successful examples of this new strategy are ALK inhibitors in ALK translocated NSCLC (less than 5% frequency) and EGFR inhibitors in EGFR mutant NSCLC (approximately 5% frequency). Selecting molecularly stratified patient populations for studies benefits the patient as it increases the odds of obtaining benefit from experimental treatment, especially in early clinical trials. Moreover it increases the speed and efficacy of drug development as signs of efficacy are picked up in earlier phases. Therefore, broad screening of molecular lesions in the tumors of patients that are being considered for participation in trials is crucial. This pre-selection increases our ability to perform several trials in parallel and thus include more patients in more meaningful trials. With the still dismal prognosis of patients with metastatic cancer, increasing the accrual rate to pivotal trials in selected patient populations is a key factor in improving prognosis.
The advent of Next Generation Sequencing (NGS) platforms enables us to probe a limited number of cancer related genes within 2-4 weeks. We have extensively piloted this approach and are now able to deliver clinically meaningful turn-around-times. This development enables us to use this technology to enrich clinical trials using targeted therapies for patients with specific mutations.
We will obtain tumor biopsies of a metastatic or locally advanced lesion and a peripheral blood sample from all patients included in the trial; the biopsies to obtain information on the tumor related genetic mutations (mutational profile) and the blood samples to assess each patient's germline DNA background variation. As patients will be asked to undergo an invasive procedure it is important to address the potential safety issues. Review of the literature and our own experience show that tumor biopsies can be performed with only minor complications and acceptable risks. We will recruit patients with metastatic or locally advanced solid tumors from patients that can potentially be included in clinical trials.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Amsterdam, Países Bajos
- Antoni van Leeuwenhoek Ziekenhuis
-
Rotterdam, Países Bajos
- Erasmus Medical Center
-
Utrecht, Países Bajos, 3508 GX
- University Medical Center Utrecht
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Locally advanced (incurable) or metastatic cancer from a histological or cytological proven solid tumor
- Indication for systemic treatment with anti-cancer agents (with no treatment options with curative intent)
- Measurable locally advanced (incurable) or metastatic lesion(s), according to RECIST 1.1 criteria.
- Safe biopsy of a metastatic or locally advanced lesion possible
- No contraindications for lidocaine (or its derivatives) and/or midazolam and/or phentanyl
- Adequate organ function
- WHO performance status 0-2
- Age > 18 yr
- Expected adequacy to follow up
- Written informed consent
Exclusion Criteria:
• If one or more of the above mentioned inclusion criteria is not met
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: Histological biopsy procedure
This is a diagnostic multicenter study combining histological biopsy of tumor material with DNA sequencing using Ion Torrent®, Next Generation Sequencing (NGS) platform.
The study aims improve stratification of cancer patients by obtaining fresh tumor biopsies for next-generation sequencing for participation in clinical trials.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Percentage of screened patients allocated to trials based upon outcome of genetic screening effort.
Periodo de tiempo: 1 year
|
1 year
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number and nature of (serious) adverse events of the performed histological biopsies.
Periodo de tiempo: 2 days after each biopsy procedure
|
2 days after each biopsy procedure
|
Number of samples stored for future related research.
Periodo de tiempo: 1 year
|
1 year
|
Number of samples with an adequate microRNA, (phospho)proteomic profiles and organoid cultures that allows biomarker discovery efforts. These profiles will be deposited in the CPCT database.
Periodo de tiempo: 1 year
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marlies Langenberg, MD, PhD, UMC Utrecht
- Investigador principal: Neeltje Steeghs, MD, PhD, Antoni van Leeuwenhoek Hospital
- Investigador principal: Maja J.A. de Jonge, MD, PhD, Erasmus Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
- NL.45677.041.13
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. .
Ensayos clínicos sobre Tumores sólidos
-
AstraZenecaReclutamientoAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, cáncer gástrico, de mama y de ovarioEspaña, Estados Unidos, Bélgica, Reino Unido, Francia, Hungría, Canadá, Corea, república de, Australia
Ensayos clínicos sobre Procedimiento de biopsia histológica
-
Aquyre Bioscience, IncBoston University; Fox Chase Cancer Center; Johnson & JohnsonReclutamiento
-
University Hospital, Basel, SwitzerlandTerminadoBiopsia de Médula ÓseaSuiza
-
Cliniques universitaires Saint-Luc- Université...Université de LiègeReclutamientoFibrosis quística | BiomarcadoresBélgica
-
Samsung Medical CenterDesconocido