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Identification of Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais , Normandy and Picardy Regions (FRISC)

C

Centre Hospitalier Universitaire, Amiens

Status

Unknown

Conditions

Cancer of Kidney

Study type

Observational

Funder types

Other

Identifiers

NCT02121730
PI2012_843_0006

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2,800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

2,800 participants in 1 patient group

Kidney Transplantation
Description:
Patients who had undergone renal transplantation for 10 years in the interregion Northwest (Normandy, Picardy and Nord-Pas de Calais).

Trial contacts and locations

4

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Central trial contact

Gabriel CHOUKROUN, MD, PhD; Pauline GUFFROY

Data sourced from clinicaltrials.gov

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