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

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ClinicalTrials.gov Identifier: NCT02900040
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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

Condition or disease Intervention/treatment
Kidney Transplantation Other: kidney transplantation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
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 Start Date : January 1994
Estimated Primary Completion Date : January 2050
Estimated Study Completion Date : January 2050

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Proportion of participants with Overall Survival [ Time Frame: 2 years ]
  2. Proportion of participants with Overall Survival [ Time Frame: 4 years ]
  3. Proportion of participants with Overall Survival [ Time Frame: 6 years ]

Secondary Outcome Measures :
  1. expansion of effector memory CD8+ T cells dosage [ Time Frame: 1 year ]
    potential marker for acute graft dysfunction

  2. expansion of effector memory CD8+ T cells dosage [ Time Frame: 6 years ]
    potential marker for late graft dysfunction


Biospecimen Retention:   Samples With DNA
peripheral blood cells, serum, plasma, urine, m-RNA, and DNA of recipients and donors


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • over the age of 18 years
  • with renal transplant

Exclusion Criteria:

  • minor
  • pediatric transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900040


Contacts
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Contact: Magali Giral, PU-PH +33 (0)2 40 08 74 43 mgiral@chu-nantes.fr

Locations
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France
Docteur Buron Recruiting
Lyon, France, 69002
Professeur Mourad Recruiting
Montpellier, France, 34295
Professeur Kessler Recruiting
Nancy, France, 54035
Professeur Ladriere Recruiting
Nancy, France, 54035
Pr Cassuto Recruiting
Nice, France, 06003
Professeur Kreis Recruiting
Paris, France, 75184
Professeur Legendre Recruiting
Paris, France, 75184
Professeur Rostaing Recruiting
Toulouse, France, 31400
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Magali Giral, PU-PH Nantes Universuty Hospital

Additional Information:

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02900040    
Other Study ID Numbers: RC12_0452
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016