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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

Tracking Information
First Submitted Date September 9, 2016
First Posted Date September 14, 2016
Last Update Posted Date September 15, 2016
Study Start Date January 1994
Estimated Primary Completion Date January 2050   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 14, 2016)
  • Proportion of participants with Overall Survival [ Time Frame: 2 years ]
  • Proportion of participants with Overall Survival [ Time Frame: 4 years ]
  • Proportion of participants with Overall Survival [ Time Frame: 6 years ]
Original Primary Outcome Measures
 (submitted: September 13, 2016)
  • survival analysis [ Time Frame: 2 years ]
  • survival analysis [ Time Frame: 4 years ]
  • survival analysis [ Time Frame: 6 years ]
Change History
Current Secondary Outcome Measures
 (submitted: September 14, 2016)
  • expansion of effector memory CD8+ T cells dosage [ Time Frame: 1 year ]
    potential marker for acute graft dysfunction
  • expansion of effector memory CD8+ T cells dosage [ Time Frame: 6 years ]
    potential marker for late graft dysfunction
Original Secondary Outcome Measures
 (submitted: September 13, 2016)
  • blood biomarkers dosage [ Time Frame: 1 year ]
    potential marker for acute graft dysfunction
  • blood biomarkers dosage [ Time Frame: 6 years ]
    potential marker for late graft dysfunction
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 30 Years
Biospecimen Retention:   Samples With DNA
Description:
peripheral blood cells, serum, plasma, urine, m-RNA, and DNA of recipients and donors
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.
Condition Kidney Transplantation
Intervention Other: kidney transplantation
Study Groups/Cohorts patients with kidney transplantations
patients with kidney transplantations
Intervention: Other: kidney transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 13, 2016)
30000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2050
Estimated Primary Completion Date January 2050   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • over the age of 18 years
  • with renal transplant

Exclusion Criteria:

  • minor
  • pediatric transplantation
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Magali Giral, PU-PH +33 (0)2 40 08 74 43 mgiral@chu-nantes.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02900040
Other Study ID Numbers RC12_0452
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Magali Giral, PU-PH Nantes Universuty Hospital
PRS Account Nantes University Hospital
Verification Date September 2016