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Renal HYPODYSPLASIA : Genetic and Familial Assessment (HDR)

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ClinicalTrials.gov Identifier: NCT00925379
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date June 19, 2009
First Posted Date June 22, 2009
Last Update Posted Date July 28, 2014
Study Start Date April 2009
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2010)
Evaluation of the heritability of renal HYPODYSPLASIA (on the renal ultra sound) and DNA collection to make possible identification of predisposing genes [ Time Frame: the same day ]
Original Primary Outcome Measures
 (submitted: June 19, 2009)
Evaluation of the heritability of renal hyposdysplasia and DNA collection to make possible identification of predisposing genes [ Time Frame: the same day ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Renal HYPODYSPLASIA : Genetic and Familial Assessment
Official Title Renal HYPODYSPLASIA;Study of Familial Cases and Search for Predisposing Genes
Brief Summary Evaluation of the frequency of familial cases of renal HYPODYSPLASIA
Detailed Description

DNA collection from the propositus and its family. A questionnaire will be filled by the parents to seek other affected individual in the family.With another affected member, DNA collection will be collected from the whole family.

A renal ultrasound will be prescribed for the parents, brothers and sisters.

Study Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA collection from the propositus and its parents and in case of families with more than one affected member, collection of DNA from the all family.
Sampling Method Non-Probability Sample
Study Population Children with a bilateral renal hypodysplasia
Condition Renal HYPODYSPLASIA, Nonsyndromic, 1
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Completed
Actual Enrollment
 (submitted: July 25, 2014)
342
Original Estimated Enrollment
 (submitted: June 19, 2009)
300
Actual Study Completion Date July 2014
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria :

- Children aged more than 3 months and less than 18 years old with a renal bilateral HYPODYSPLASIA set by renal ultrasound examination :

  • renal size < -2DS
  • with/or hyperechogenicity or lack of cortical-medullary differentiation
  • with/or renal cysts

Exclusion criteria :

  • Bladder uropathy or sus-bladder uropathy
  • Recessive or dominant renal polycystic disease
  • Bardet-Biedl syndrome and other malformative syndromes except renal coloboma syndrome, Renal cysts and diabetes syndrome RCAD
  • Lack of written informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00925379
Other Study ID Numbers P070151
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Remi Salomon, MD, PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Vincent Guigonis, MD, PhD University Hospital, Limoges
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2014