Clinical trial NCT02121730: Identification of Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais , Normandy and Picardy Regions
Official title: Identification of Key Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais, Normandy and Picardy Regions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer of Kidney
Keywords: grafting kidney
Cancer
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 2800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had undergone renal transplantation for 10 years in the French interregion Northwest (Normandy, Picardy and Nord-Pas de Calais).

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Association between neoplastic complications and cancers
timeFrame: 10 years
Secondary outcomes:
measure: Risk factors
timeFrame: 10 years
measure: Incidence
timeFrame: 10 years
measure: Typology of cancers
timeFrame: 10 years
measure: Survival prognosis
timeFrame: 10 years
measure: Survival factors
timeFrame: 10 years
measure: Graft survival
timeFrame: 10 years
measure: Rejection number
timeFrame: 10 years
measure: Renal function after cancer
timeFrame: 10 years
measure: Cancer management
timeFrame: 10 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Caen
country: France
facility: CHU CAEN
city: Lille
country: France
facility: Chru Lille
city: Rouen
country: France
facility: Chu Rouen
Study officials:
affiliation: CHU Amiens
name: Gabriel Choukroun, MD, PhD
role: STUDY_DIRECTOR
affiliation: CHRU LILLE
name: Marc Hazzan, MD, PhD
role: STUDY_CHAIR
affiliation: CHU CAEN
name: Bruno Hurault de Ligny, MD, PhD
role: STUDY_CHAIR
affiliation: CHU Rouen
name: Michel Godin, MD, PhD
role: STUDY_CHAIR
References: