Identification of Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais , Normandy and Picardy Regions (FRISC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02121730|
Recruitment Status : Unknown
Verified April 2016 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was: Recruiting
First Posted : April 23, 2014
Last Update Posted : April 26, 2016
Kidney transplantation is now the treatment of choice for end-stage renal disease (ESRD). Between 2800 and 3000 kidney transplants are performed each year in France and more than 33 000 patients are living with a functioning graft.
Preventing allograft rejection requires the use of immunosuppressive therapy, the intensity decreases as the distance from the day of transplantation. Unfortunately, treatment favors certain complications, including infectious and neoplastic. These represent a major cause of mortality in these patients. If the frequency of skin cancer is greatly increased in this population, that of solid tumors remains a concern. Approximately 20% of patients develop cancer after 10 years of graft , half non- skin cancers, the main risk factor is immunosuppressive therapy .
The aim of the study is to evaluate, in a large population of patients treated in 4 regions ( the Nord-Pas de Calais, the Upper and Lower Normandy and Picardy) risk factors (in particular the nature of the immunosuppressive treatment) of developing a neoplastic complication, skin cancers and solid tumors, after renal transplantation.
|Condition or disease|
|Cancer of Kidney|
A retrospective analysis of the previous 10 years, from 2002 to 2011 will be conducted. This study will better understand the epidemiology of these complications but also allow to identify risk factors associated, including demographic, environmental and related to immunosuppressive therapy.
Thereafter, we hope to implement preventive measures or prospective studies, allowing us to reduce the prevalence of this complication.
|Study Type :||Observational|
|Estimated Enrollment :||2800 participants|
|Official Title:||Identification of Key Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais, Normandy and Picardy Regions|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2017|
Patients who had undergone renal transplantation for 10 years in the interregion Northwest (Normandy, Picardy and Nord-Pas de Calais).
- Association between neoplastic complications and cancers [ Time Frame: 10 years ]Correlation, in a population of renal transplant patients followed in interregion Northwest, of the association of neoplastic complications after renal transplantation, skin cancers and solid tumors outside the non-Hodgkin's lymphoma and the terms of immunosuppressive treatment used
- Risk factors [ Time Frame: 10 years ]Identify the main risk factors for developing cancer after transplantation, besides immunosuppressive therapy
- Incidence [ Time Frame: 10 years ]Evaluate the incidence of neoplastic complications after renal transplantation in interregion Northwest
- Typology of cancers [ Time Frame: 10 years ]Assess the distribution and respective frequency of different types of cancer, skin and solid tumors in this group of patients
- Survival prognosis [ Time Frame: 10 years ]Establish the prognosis and survival of transplanted patients with a diagnosis of cancer after transplantation
- Survival factors [ Time Frame: 10 years ]Analyze the factors associated with the survival of transplanted patients who developed cancer after transplantation
- Graft survival [ Time Frame: 10 years ]Evaluate graft survival in the group of patients who develop post- transplantation cancer , especially after cancer diagnosis
- Rejection number [ Time Frame: 10 years ]Determine the number of cellular acute rejection and humoral rejections in patients who developed cancer and those free from this complication and analyze the prevalence of releases in the period following the diagnosis of cancer
- Renal function after cancer [ Time Frame: 10 years ]To analyze the evolution of renal function after cancer diagnosis
- Cancer management [ Time Frame: 10 years ]Analyze the management of these cancers, in particular as regards the strategy of immunosuppressive therapy after cancer diagnosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121730
|Contact: Gabriel CHOUKROUN, MD, PhD||+333 22 45 58 firstname.lastname@example.org|
|Contact: Pauline GUFFROY||Guffroy.Pauline@chu-amiens.fr|
|Amiens, France, 80000|
|Principal Investigator: Gabriel Choukroun, MD, PhD|
|CHU CAEN||Not yet recruiting|
|Caen, France, 14000|
|Contact: Bruno Hurault de Ligny, MD, PhD email@example.com|
|Principal Investigator: Bruno Bruno Hurault de Ligny, MD, PhD|
|Chru Lille||Not yet recruiting|
|Lille, France, 59000|
|Contact: Marc HAZZAN, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Marc Hazzan, MD, PhD|
|Chu Rouen||Not yet recruiting|
|Rouen, France, 76000|
|Contact: Michel GODIN, MD, PhD email@example.com|
|Principal Investigator: Michel Godin, MD, PhD|
|Study Director:||Gabriel Choukroun, MD, PhD||CHU Amiens|
|Study Chair:||Marc Hazzan, MD, PhD||CHRU Lille|
|Study Chair:||Bruno Hurault de Ligny, MD, PhD||CHU Caen|
|Study Chair:||Michel Godin, MD, PhD||CHU Rouen|