Identification of Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais , Normandy and Picardy Regions (FRISC)
Identification of Key Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais, Normandy and Picardy Regions
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Amiens, France, 80000
- Recrutement
- CHU Amiens
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Chercheur principal:
- Gabriel Choukroun, MD, PhD
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Caen, France, 14000
- Pas encore de recrutement
- CHU Caen
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Contact:
- Bruno Hurault de Ligny, MD, PhD
- E-mail: huraultdeligny-b@chu-caen.fr
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Chercheur principal:
- Bruno Bruno Hurault de Ligny, MD, PhD
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Lille, France, 59000
- Pas encore de recrutement
- CHRU Lille
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Contact:
- Marc HAZZAN, MD, PhD
- E-mail: m-hazzan@chru-lille.fr
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Chercheur principal:
- Marc Hazzan, MD, PhD
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Rouen, France, 76000
- Pas encore de recrutement
- CHU Rouen
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Contact:
- Michel GODIN, MD, PhD
- E-mail: michel.godin@chu-rouen.fr
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Chercheur principal:
- Michel Godin, MD, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- All adult renal transplant patients in the 4 centers of interregion North - West
- Patients transplanted during the period from 1 January 2002 and 31 December 2011
- Patients recipients of first, second or third renal transplantation
- Patients transplant recipients from a living or deceased donor whatever the immunological risk
- Eligible patients will be included after being informed by their doctor and after accepting their data to be processed in the framework of this study
- Patient with a health insurance coverage
Exclusion Criteria:
- Patients transplanted as child
- Patients transplanted before 1 January 2002
- Patients followed in the interregion but transplanted in another center
- Patients recipients of a double transplant (two kidneys or kidney plus other organ)
- Patients that do not accept their medical data to be included in the database
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Kidney Transplantation
Patients who had undergone renal transplantation for 10 years in the interregion Northwest (Normandy, Picardy and Nord-Pas de Calais).
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Association between neoplastic complications and cancers
Délai: 10 years
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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
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10 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Risk factors
Délai: 10 years
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Identify the main risk factors for developing cancer after transplantation, besides immunosuppressive therapy
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10 years
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Incidence
Délai: 10 years
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Evaluate the incidence of neoplastic complications after renal transplantation in interregion Northwest
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10 years
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Typology of cancers
Délai: 10 years
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Assess the distribution and respective frequency of different types of cancer, skin and solid tumors in this group of patients
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10 years
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Survival prognosis
Délai: 10 years
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Establish the prognosis and survival of transplanted patients with a diagnosis of cancer after transplantation
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10 years
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Survival factors
Délai: 10 years
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Analyze the factors associated with the survival of transplanted patients who developed cancer after transplantation
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10 years
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Graft survival
Délai: 10 years
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Evaluate graft survival in the group of patients who develop post- transplantation cancer , especially after cancer diagnosis
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10 years
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Rejection number
Délai: 10 years
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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
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10 years
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Renal function after cancer
Délai: 10 years
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To analyze the evolution of renal function after cancer diagnosis
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10 years
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Cancer management
Délai: 10 years
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Analyze the management of these cancers, in particular as regards the strategy of immunosuppressive therapy after cancer diagnosis
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10 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Gabriel Choukroun, MD, PhD, CHU Amiens
- Chaise d'étude: Marc Hazzan, MD, PhD, CHRU Lille
- Chaise d'étude: Bruno Hurault de Ligny, MD, PhD, CHU Caen
- Chaise d'étude: Michel Godin, MD, PhD, CHU Rouen
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PI2012_843_0006
Plan pour les données individuelles des participants (IPD)
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