Clinical Database Associated With a Biological Banking Accessible to Initiate Epidemiological and Translational Collaborative Researches in Kidney Transplantation (DIVAT)

The French DIVAT: a Clinical Database Associated With a Biological Banking Accessible to Initiate Epidemiological and Translational Collaborative Researches in Kidney Transplantation

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

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplantation
• Intervention / Treatment: Other: kidney transplantation

• Study Type: Observational
• Enrollment (Anticipated): 30000

Contacts and Locations

• Study Contact: Name: Magali Giral, PU-PH; Phone Number: +33 (0)2 40 08 74 43; Email: mgiral@chu-nantes.fr

Study Locations

• France
  • Lyon, France, 69002
    • Recruiting
    • Docteur Buron
  • Montpellier, France, 34295
    • Recruiting
    • Professeur Mourad
  • Nancy, France, 54035
    • Recruiting
    • Professeur Kessler
  • Nancy, France, 54035
    • Recruiting
    • Professeur Ladriere
  • Nice, France, 06003
    • Recruiting
    • Pr Cassuto
  • Paris, France, 75184
    • Recruiting
    • Professeur Kreis
  • Paris, France, 75184
    • Recruiting
    • Professeur Legendre
  • Toulouse, France, 31400
    • Recruiting
    • Professeur Rostaing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• over the age of 18 years
• with renal transplant

Exclusion Criteria:

• minor
• pediatric transplantation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with kidney transplantations	Other: kidney transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with Overall Survival	2 years
Proportion of participants with Overall Survival	4 years
Proportion of participants with Overall Survival	6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
expansion of effector memory CD8+ T cells dosage	potential marker for acute graft dysfunction	1 year
expansion of effector memory CD8+ T cells dosage	potential marker for late graft dysfunction	6 years

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Magali Giral, PU-PH, Nantes Universuty Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 1994
• Primary Completion (Anticipated): January 1, 2050
• Study Completion (Anticipated): January 1, 2050

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Estimate): September 15, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: RC12_0452