Clinical trial NCT02900040: Clinical Database Associated With a Biological Banking Accessible to Initiate Epidemiological and Translational Collaborative Researches in Kidney Transplantation
Official title: The French DIVAT: a Clinical Database Associated With a Biological Banking Accessible to Initiate Epidemiological and Translational Collaborative Researches in Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplantation
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eight French transplantation centers participate to the DIVAT network: Nantes, Paris Necker, Nancy and Montpellier since 1994, Toulouse since 1997, Lyon since 2006, and Paris Saint-Louis and Nice that joined the network since 2013. All patients over the age of 18 years, who received a renal transplant, are included. No other particular inclusion criteria exist.

Brief summary: The French DIVAT (standing for Données Informatisées et VAlidées en Transplantation in french, and in English "Computerized and VAlidated Data in Transplantation" ) cohort was Kicked off in 1994 by the Transplantation Urology Nephrology Institute of the Nantes University Hospital in France. The primary objective of this multicenter computerized database was to enable prospective clinical and epidemiological research studies concerning kidney transplant recipients, particularly focusing on mid- and long-term clinical outcomes, therapeutic strategies and public health issues. The patient-case system of the DIVAT cohort allows the monitoring of medical records of all patient-specific and allograft-specific data, including bio-banking since 2005. Data are collected from the date of transplantation until the graft failure, at each scheduled outpatient visit or hospital admission motivating by a new clinical, therapeutical or biological expression. The DIVAT cohort contains information on more than 11000 transplant recipients between 1994 and today, issued from 8 French university hospitals centers (the DIVAT Network is organized by a consortium agreement). 18% of all patients underwent retransplantation and 11% of all kidney transplants originated from living donors. The DIVAT network heavily works to ensure a high-quality data collection with the aim of exploring adequately the complex post-transplantation process. The Divat network encourage collaborations and enables interested researchers to submit a research project by completing a request form available on the DIVAT website (http://www.divat.fr/en) describing the context, objectives and design of the study


Eligibility criteria: Inclusion Criteria:

* over the age of 18 years
* with renal transplant

Exclusion Criteria:

* minor
* pediatric transplantation

Primary outcomes:
measure: Proportion of participants with Overall Survival
timeFrame: 2 years
measure: Proportion of participants with Overall Survival
timeFrame: 4 years
measure: Proportion of participants with Overall Survival
timeFrame: 6 years
Secondary outcomes:
measure: expansion of effector memory CD8+ T cells dosage
timeFrame: 1 year
measure: expansion of effector memory CD8+ T cells dosage
timeFrame: 6 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Docteur Buron
city: Montpellier
country: France
facility: Professeur Mourad
city: Nancy
country: France
facility: Professeur Kessler
city: Nancy
country: France
facility: Professeur Ladriere
city: Nice
country: France
facility: Pr Cassuto
city: Paris
country: France
facility: Professeur Kreis
city: Paris
country: France
facility: Professeur Legendre
city: Toulouse
country: France
facility: Professeur Rostaing
Study officials:
affiliation: Nantes Universuty Hospital
name: Magali Giral, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: