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IDMet (RaDiCo Cohort) (RaDiCo-IDMet) (IDMet)

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ClinicalTrials.gov Identifier: NCT05945576
Recruitment Status : Recruiting
First Posted : July 14, 2023
Last Update Posted : July 14, 2023
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Tracking Information
First Submitted Date June 26, 2023
First Posted Date July 14, 2023
Last Update Posted Date July 14, 2023
Actual Study Start Date March 10, 2017
Estimated Primary Completion Date March 10, 2032   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 6, 2023)
  • The clinical characteristics of IDs in pediatric and adult's patients. [ Time Frame: Through study completion, an average of 10 years ]
  • The genetic characteristics of IDs in pediatric and adult's patients. [ Time Frame: Through study completion, an average of 10 years ]
  • The biological characteristics of IDs in pediatric and adult's patients. [ Time Frame: Through study completion, an average of 10 years ]
  • The morphometric characteristics of IDs in pediatric and adult's patients. [ Time Frame: Through study completion, an average of 10 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 6, 2023)
  • Search for an association between the metabolic phenotype of IDs patients' and their biological profil. [ Time Frame: At the time of diagnosis (or at first measurement) ]
  • Determination of the prevalence of metabolic abnormalities (MA). [ Time Frame: At inclusion ]
  • Estimation of the risk for metabolic complications such as obesity, diabetes, cardiovascular disease (CVD), metabolic syndrome. [ Time Frame: 10 years after ]
  • Description of different therapeutic approaches and identification of a common base for all IDs. [ Time Frame: Through study completion, an average of 10 years ]
  • Variations of quality-of-life scores. [ Time Frame: Through study completion, an average of 10 years ]
  • Analyse of (epi)genetic mutations transmission in proband and relatives. [ Time Frame: Through study completion, an average of 10 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 6, 2023)
  • Identification of different metabolic profile which allow a clinical classification of IDs. [ Time Frame: Through study completion, an average of 10 years ]
  • Description and identification of the most relevant biological and clinical practices for diagnostic and follow-up of ID patients. [ Time Frame: Through study completion, an average of 10 years ]
  • Identification of a group of French patients with the same characteristics. [ Time Frame: At inclusion ]
  • Search of an association between blood metabolic markers, genetic pattern and gut microbiota. [ Time Frame: Through study completion, an average of 10 years ]
  • Description of different scientific rational for transferring a therapeutic approach (clinical guidelines) from an ID to another (identification of common phenotype, i.e. metabolic profile). [ Time Frame: Through study completion, an average of 10 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title IDMet (RaDiCo Cohort) (RaDiCo-IDMet)
Official Title National Cohort on Imprinting Disorders and Their Metabolic Consequences
Brief Summary

The goal of this observational study is to describe the natural history of imprinting disorders (IDs) according to their metabolic profile in all patients (adults and children) affected with an ID regardless of the severity of the disease, with a molecular characterization, with a signed informed consent for all subjects, followed in one partner's center.

The main questions it aims to answer are:

  • Can we identify common metabolic profiles for all imprinted diseases?
  • Which imprinting disorders have an impact on the metabolic profiles of IDs?
  • Which are the metabolic risks associated to IDs?
  • Can we use the metabolic profiles for the clinical classification and prognosis of IDs?
  • Are there common therapeutic approaches for all IDs?
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients (adults and children) affected with an ID regardless of the severity of the disease, with a molecular characterization, with a signed informed consent for all subjects, followed in one partner's center.
Condition
  • Silver Russell Syndrome
  • Beckwith-Wiedemann Syndrome
  • Transient Neonatal Diabetes Mellitus
  • Angelman Syndrome
  • Prader-Willi Syndrome
  • Temple Syndrome
  • Kagami-Ogata Syndrome
  • Pseudohypoparathyroidism
  • Familial Precocious Puberty
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 Recruiting
Estimated Enrollment
 (submitted: July 6, 2023)		 2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 10, 2032
Estimated Primary Completion Date March 10, 2032   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients (adults and children) affected with an ID regardless of the severity of the disease
  • A confirmed diagnosis of ID (based on molecular diagnosis)
  • A signed informed consent for adults or signed informed consent of parents/guardians of minors/ protected adult.

Non-Inclusion Criteria:

There are no non-inclusion criteria.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Agnès LINGLART +33 1 45 21 78 53 agnes.linglart@aphp.fr
Contact: Irène NETCHINE irene.netchine@aphp.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT05945576
Other Study ID Numbers C15-63
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Institut National de la Santé Et de la Recherche Médicale, France
Original Responsible Party Same as current
Current Study Sponsor Institut National de la Santé Et de la Recherche Médicale, France
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Agnès LINGLART Inserm U1169
PRS Account Institut National de la Santé Et de la Recherche Médicale, France
Verification Date June 2023