Study of Cancers After Solid Organs Transplants

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EstadoTerminado

Patrocinadores

Assistance Publique - Hôpitaux de Paris

Colaboradores

CANCEROPOLE Ile-de-France

ENSAYO CLÍNICO: NCT00948883

BioSeek: nct00948883

Palabras clave

Abstracto

About 1500 solid organs transplants are performed each year in the Paris agglomeration.

Cancer risk in the transplanted is about three times higher than in a population of the same age without any organ transplant. Thus cancer is an important problem for organ transplant.

These cancers can be related to many factors :

- Post-transplant cancers are due in part to the non specific immunosuppression, which leads to oncogenic viruses replication, and then produces virus inducted cancers (as lymphoma due to EBV virus).

- Post-transplant cancers can also be due to the carcinogenic factors of the immunosuppressive drugs (as cyclosporine or tacrolimus, which can cause the appearance of metastases). However, a new type of immunosuppressive drugs (mTOR inhibitors) appear to have anti-cancer properties.

- Post-transplant cancers which are not virus-inducted can be relied to genetic factors of the transplanted patient and/or the transplant donor.

There are 4 axes in this study :

- Axis 1 : Epidemiological, clinical and biological study of the incident cancers in transplanted patients.

- Axis 2 : Qualitative and quantitative immunological study of lymphocyte cells by the transplanted patient (determine their characteristics when a cancer appears).

- Axis 3 : Pathological and genetic study of the post-transplant cancer cells (see if the cancer is caused by the donor or the recipient). Creation of a biobank.

- Axis 4 : Pharmacogenetic study of the immunosuppressive drugs (determine the impact of patient genetic variability on tolerance and efficiency of the immunosuppressive drugs).

Descripción

This is an observational and comparative study (2 control patients are recruited for each 1 case patient).

A case patient is a patient who has developed a cancer after his/her transplant.

A control patient is a patient who has not developed a cancer after his/her transplant.

These 2 groups will be matched according to specific inclusion criteria.

fechas

Verificado por última vez:	03/31/2013
Primero enviado:	07/27/2009
Inscripción estimada enviada:	07/27/2009
Publicado por primera vez:	07/28/2009
Última actualización enviada:	04/02/2013
Última actualización publicada:	04/03/2013
Fecha de inicio real del estudio:	09/30/2008
Fecha estimada de finalización primaria:	06/30/2011
Fecha estimada de finalización del estudio:	06/30/2011

Condición o enfermedad

Cancer

Organ Transplantation

Fase

Grupos de brazos

Brazo	Intervención / tratamiento
Patient-Case Transplanted patient with cancer
Patient-Control Transplanted patient without cancer

Criterio de elegibilidad

Edades elegibles para estudiar	18 Years A 18 Years
Sexos elegibles para estudiar	All
Método de muestreo	Non-Probability Sample
Acepta voluntarios saludables	si
Criterios	Inclusion Criteria: - Man or woman after 18 years old - Transplanted with a solid organ (heart, kidney, lung,liver) - Informed Consent Form signed - For the patients-case: Patients who developed a post-transplant cancer - For the patients-control: Patients who didn't develop a post-transplant cancer Exclusion Criteria: - Cancer as transplant indication ( except liver ) - HIV positive

Salir

Medidas de resultado primarias

1. Incidence of cancer among transplanted patients. [At the day of blood collection]

Medidas de resultado secundarias

1. Characteristics of the tumors. [At the day of blood collection]

2. Risk factors of the tumors. [At the day of blood collection]

Study of Cancers After Solid Organs Transplants

Palabras clave

metástasis

cáncer

linfoma

antineoplásico