- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01280708
Protocol DIVAT-Uro
September 13, 2021 updated by: Nantes University Hospital
Establishment of a National Thematic Network in Urology for the Extension of the Cohort DIVAT (Données Informatisées et Validées en Transplantation) in Surgical Parameters of Renal and Pancreatic Transplant Patients : An Innovative Tool for the Promotion of Epidemiological Studies, Identification of Risk Factors and Good Practices in the Domain of Transplant Surgery
The aim of project DIVAT-URO (Données Informatisées et Validées en Transplantation - Urology) is to organize a thematic network in urology traced on NetWork DIVAT to supplement the medical and biological data of DIVAT existing cohort with parameters of surgical transplantation of kidney and pancreas.
These data will concern the transplantation itself and the events and complications related to surgery occurring throughout the follow-up.
The collection will involve patients in the cohort DIVAT and future patients.
This project will allow us to have the sufficiency of surgical transplantation by increasing the quantity and quality of information gathered thus avoiding the biases commonly upbraided against the retrospective studies.
Finally, by supplementing it with new parameters, it will strengthen the medical and scientific interest of the cohort DIVAT and will open new perspectives for clinical trials in surgery and work in epidemiology.Networking of urologists and the expansion of the base DIVAT would carry out research in epidemiology and factors that may play a role in the outcome of renal and pancreatic transplantation.
It would also help to define good practices.
The first study from the proposed network DIVAT-Uro is assessing the impact of vesico-ureteric reflux on the occurrence of urinary tract infections and effects on survival of the transplant in the recipient adult.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1616
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nantes, France, 44093
- Nantes University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
Patients aged over 18 years received a kidney transplant or a simultaneous pancreas-kidney transplant.
Description
Inclusion Criteria:
- Patients aged over 18 years
- Patients received a kidney transplant or a simultaneous pancreas-kidney transplant
- Patients who read the newsletter and signed the consent form on the computerization of data
Exclusion Criteria:
- Patients aged under 18 years
- Patients who did not sign the consent form
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Capture data
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Capture and standardization of data of patients aged over 18 years received a kidney transplant or a simultaneous pancreas-kidney transplant from data sources will be performed by clinical research associates.The quality of data will be validated by cross annual audits.
The statistical analysis will be made on a case by case according to clinical objectives.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Georges KARAM, Profesor, Nantes University Hospital
- Study Chair: Lionel BADET, Profesor, CHU de Lyon
- Study Chair: François IBORRA, Doctor, CHU de Montpellier
- Study Chair: Jacques HUBERT, Profesor, CHU de Nancy
- Study Chair: Arnaud MEJEAN, Profesor, Hôpital Necker - AP-HP
- Study Chair: Pascal RISCHMANN, Profesor, University Hospital, Toulouse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2012
Primary Completion (Actual)
December 31, 2013
Study Completion (Actual)
December 31, 2013
Study Registration Dates
First Submitted
January 19, 2011
First Submitted That Met QC Criteria
January 20, 2011
First Posted (Estimate)
January 21, 2011
Study Record Updates
Last Update Posted (Actual)
September 17, 2021
Last Update Submitted That Met QC Criteria
September 13, 2021
Last Verified
September 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- BRD/09/11-E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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