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Clinical Trials/NCT01565005
NCT01565005
Completed
N/A

Microcephaly Genetic Deficiency in Neural Progenitors: Genotyping, Phenotyping and Functional Neuro-anatomy and Neurobiology Comparative Primitive Microcephaly (MCPH) and the Fanconi Anemia (FA)

Assistance Publique - Hôpitaux de Paris1 site in 1 country98 target enrollmentOctober 2013
ConditionsMicrocephaly

Overview

Phase
N/A
Intervention
Not specified
Conditions
Microcephaly
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
98
Locations
1
Primary Endpoint
Compare neuroradiological phenotype and cognitive functioning with other MCPH-related patients
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to:

I. Compare neuroradiological phenotype and cognitive functioning of MCPH patients caused by ASPM mutations already characterized and published (Passemard et al. 2009a) with other MCPH-related patients (patients with MCPH1, WDR62, CDK5RAP2, CEP 152, CENPJ, STIL, or PCNT mutations)

II. Describe the neuro-radiological and cognitive phenotype of microcephalic patients suffering from Fanconi anemia, and compared them to subjects with:

  • Fanconi anemia but normal OFC (head circumference)
  • MCPH patients
  • Healthy control subjects Our hypothesis is that mutations in genes responsible of microcephaly impact differentially cortical brain development and functioning

Detailed Description

Phenotyping study on 2 different cohorts of rare disease affected patients: * Group1: MCPH (including different MCPH subtypes) * Group2: Fanconi Anemia (with or without microcephaly) Inclusion criteria: Common to each group: * Age \> 3 years * Access to french "Social Security" * No contraindication for MRI Group1: * Primary microcephaly without gross malformation within or extra nervous central system * OFC \< -2SD at birth and \< -3 SD after age 6months * Mutation in one MCPH gene Group2: Proven Fanconi Anemia with: * Positive chromosome breakage blood test * One of the 3 following elements: FANCD2 positive test Fibroblast sensitivity to mitomycin Mutation in one FANC gene Control subjects: * No antecedent * Normal education Aims: 1. Description of neurological, neuropsychological and radiological phenotype for each group 2. Phenotype comparison: * groups 1\&2 * group1 or 2 with control subjects * different MCPH subtypes within group1 * with or without microcephaly within group2 3. Epidemiological data on these rare diseases in our population Protocol: Patients from both groups and control subjects will be evaluated in CIC for 1 day ½. They will be examined by a child neurologist and a geneticist. All of them will have cranial MRI (1.5Tesla). Neuropsychological assessment will be performed (Wechsler scales) for patients and control subjects.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
December 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients aged ≥ 3 years:
  • Microcephalic phenotype consistent with MCPH (recruitment already done as part of a network GIS-Rare Diseases Institute). MCPH patients have already been selected in the cohort "Robert Debré."
  • Holders of a Fanconi anemia characterized in terms of cytogenetics, enzyme and/or molecular (patients in the cohort "Saint Louis" followed by the KRC rare aplastic anemia)
  • Healthy controls aged ≥ 5 years siblings of patients with Fanconi Anemia

Exclusion Criteria

  • Patients with Fanconi anemia:
  • bone marrow \< 3 years
  • Post-transplantation neurological complications
  • developmental, genetic or environmental additional pathology

Outcomes

Primary Outcomes

Compare neuroradiological phenotype and cognitive functioning with other MCPH-related patients

Time Frame: 3 years

The purpose of this study is to: Compare neuroradiological phenotype and cognitive functioning of MCPH patients caused by ASPM mutations already characterized and published (Passemard et al. 2009a) with other MCPH-related patients (patients with MCPH1, WDR62, CDK5RAP2, CEP 152, CENPJ, STIL, or PCNT mutations)

Secondary Outcomes

  • Establish a clear organizational chart for the diagnosis of primary microcephaly(3 years)

Study Sites (1)

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