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Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function (TCF2)

This study is currently recruiting participants.
Verified September 2008 by University Hospital, Limoges
Sponsor:
ClinicalTrials.gov Identifier:
NCT00760331
First Posted: September 26, 2008
Last Update Posted: September 26, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by:
University Hospital, Limoges
  Purpose
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.

Condition
Hepatocyte Nuclear Factor 1-Beta

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Estimated Enrollment: 100
Study Start Date: June 2008
Estimated Study Completion Date: July 2028
Detailed Description:

Biologic analysis and renal ultrasonography once a year.

After puberty or before kidney transplantation

  • Abdominal and pelvic MRI
  • Intravenous Glucose Tolerance Test
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric patients presenting an abnormality of kidney developmentdue to TCF2 mutation or deletion.
Criteria

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
  Contacts and Locations
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): NCT00760331


Contacts
Contact: Vincent GUIGONIS, MD 0555056358 vincent.guigonis@chu-limoges.fr

Locations
France
CHU de Limoges Recruiting
Limoges, France
Principal Investigator: Vincent GUIGONIS, MD         
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Vincent GUIGONIS, MD University Hospital, Limoges
  More Information

Responsible Party: Norbert VIDAL, CHU de Limoges
ClinicalTrials.gov Identifier: NCT00760331     History of Changes
Other Study ID Numbers: I06026
First Submitted: September 25, 2008
First Posted: September 26, 2008
Last Update Posted: September 26, 2008
Last Verified: September 2008

Keywords provided by University Hospital, Limoges:
HNF1B
TCF2
MODY-5
CAKUT
Anomaly of renal development


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