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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2008 by University Hospital, Limoges
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00760331
First received: September 25, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Norbert VIDAL, CHU de Limoges
ClinicalTrials.gov Identifier: NCT00760331     History of Changes
Other Study ID Numbers: I06026
Study First Received: September 25, 2008
Last Updated: September 25, 2008
Health Authority: France: Direction Générale de la Santé

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

ClinicalTrials.gov processed this record on November 20, 2014