- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00760331
Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function (TCF2)
August 10, 2018 updated by: University Hospital, Limoges
A Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function
Anomalies of renal development are well know for patients treated for MODY-5 diabetes due to TCF2 mutation.A recent study confirms the existence of pediatric patients having TCF2 mutation but presenting renal anomalies alone.Endocrine and renal evolution of these patients is unknown.The aim of this study is to follow a cohort of patients with TCF2 mutation and initially presenting renal anomalies alone.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Biologic analysis and renal ultrasonography once a year.
After puberty or before kidney transplantation
- Abdominal and pelvic MRI
- Intravenous Glucose Tolerance Test
Study Type
Observational
Enrollment (Anticipated)
100
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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Limoges, France
- CHU de Limoges
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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
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
pediatric patients presenting an abnormality of kidney developmentdue to TCF2 mutation or deletion.
Description
Inclusion Criteria:
- Patients presenting an anomaly of renal development due to TCF2 mutation
- Age<18 years old
Exclusion Criteria:
- Anomaly of renal development without TCF2 mutation
- Age≥18 years old
- Parents or patients refusing to participate to the study
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2008
Primary Completion (Anticipated)
July 1, 2033
Study Completion (Anticipated)
December 1, 2033
Study Registration Dates
First Submitted
September 25, 2008
First Submitted That Met QC Criteria
September 25, 2008
First Posted (Estimate)
September 26, 2008
Study Record Updates
Last Update Posted (Actual)
August 13, 2018
Last Update Submitted That Met QC Criteria
August 10, 2018
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- I06026
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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