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RecruitingNCT07038239PhenoMORC2Updated Jun 18, 2026

Genotype/Phenotype Correlation of MORC2 Mutations

An observational study in Charcot Marie Tooth Disease, DIFGAN and Developmental Delay (Disorder), sponsored by Hospices Civils de Lyon. Recruiting at 12 sites in France. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
45
Ages
4 Years and older
Sex
All
01

Study summary

The Microrchidia CW-type zinc finger 2 (MORC2) gene encodes a protein expressed in all tissues and enriched in the brain. It is involved in Charcot-Marie-Tooth disease, with mire than 30 families presenting MORC2 mutations. Recently, MORC2 mutation have been shown to be responsible for more complex phenotypes like DIFGAN: developmental delay, impaired growth, dysmorphic facies and axonal neuropathy.

Different mutations are responsible from a diverse spectrum of phenotype, from CMT to DIFGAN.

MORC2 is involved, through its ATPase activity, in DNA repair, chromatin remodeling and epigenetic silencing via the Human silencing hub (HUSH) complex. Our hypothesis is that the hypo- or hyper-activation of the HUSH complex by different MORC2 mutations could be responsible for different phenotypes in patients. The aim of this study is to perform a genotype-phenotype correlation study in patients presenting MORC2 mutations.

02

Conditions studied

  • Charcot Marie Tooth Disease
  • DIFGAN
  • Developmental Delay (Disorder)
  • Impaired Growth
  • Dysmorphic Facies and Axonal Neuropathy

Keywords

  • Charcot-Marie-Tooth
  • DIFGAN
  • Human silencing hub complex
  • genotype-phenotype correlation
  • MORC2
  • DNA dalage repair
  • transcriptional modulation
  • EPIGENETIC
03

Who can participate

Ages eligible
4 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study will focus on children and adults suffering from a MORC2 gene mutation, and presenting a CMT or DIFGAN phenotype.

Inclusion criteria

  • Presence of a mutation in the MORC2 gene, identified during an evaluation for peripheral neuropathy or intellectual disability
  • Patient has undergone electromyography (EMG) or is able to undergo EMG during the inclusion visit
  • Affiliation with the national health insurance system
  • Informed consent from the patient if an adult, or from parents/legal guardians if the patient is a minor

Exclusion criteria

Exclusion Criteria:

  • Presence of another mutation responsible for peripheral neuropathy or intellectual disability
  • Refusal to undergo biological sample collection
  • Regulatory exclusion criteria:
  • Pregnant, postpartum, or breastfeeding women
  • Individuals deprived of liberty by judicial or administrative decision
  • Individuals not affiliated with a social security system or not benefiting from an equivalent health coverage scheme
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
45 participants (estimated)
Patient registry
No

Groups and cohorts

  • Charcot-Marie-Tooth patients : Patients presenting with length-dependent sensitive-motor axonal neur

    Patients presenting with length-dependent sensitive-motor axonal neuropathy

    Diagnostic Test: Skin biopsy · Diagnostic Test: Blood sample

  • DIFGAN patients

    Patients presenting with DIFGAN syndrome : developmental delay, impaired growth, dysmorphic facies and axonal neuropathy

    Diagnostic Test: Skin biopsy · Diagnostic Test: Blood sample

  • Control

    Control group without any neurological disorder

Interventions

  • Diagnostic testSkin biopsy

    under the arm using a 3 mm punch, with local anaesthesia, in the investigating centres.

  • Diagnostic testBlood sample

    3 classical 4ml tubes samples per patients, using the routine blood sampling technique, in the investigating centres. For children, blood sampling volume will be adapted to the patient's weight according to L.1121-1 of the French public health code.

05

What researchers measure

Primary outcomes

  1. Epigenetic biomarker levels

    Quantification of epigenetic biomarkers in patient and control-derived cells (number of reads in patients vs controls)

    Time frame: At inclusion

Secondary outcomes

  1. RNA-seq

    quantification of specific mRNA sequences in patient-derived cells (RNA copy number in patient vs control)

    Time frame: At inclusion

  2. Detection and quantification of specific nucleic acid biomarkers in patient's serum

    Quantification of nucleic acid biomarkers in the patient's serum (number of reads in patients vs control)

    Time frame: At inclusion

  3. Quantification of nucleic acid biomarkers in patient's cerebrospinal fluid

    Quantification of nucleic acid biomarkers in the patient's cerebrospinal fluid (CSF) (number of reads in patients vs control)

    Time frame: At inclusion

  4. Quantification of proteic biomarkers in patient's serum

    Quantification of proteic biomarkers in the patient's serum (µg/mL)

    Time frame: At inclusion

  5. Quantification of proteic biomarkers in patient's cerebrospinal fluid (CSF)

    Quantification of proteic biomarkers in the patient's cerebrospinal fluid (CSF)(µg/mL)

    Time frame: At inclusion

06

Study locations

12 of 12 sites recruiting
  • CHU de Besançon
    Besançon, 25030, France
    Recruiting
  • CHRU Brest
    Brest, 29200, France
    • Audebert Bellanger, MD · Contact
    Recruiting
  • CHU Grenoble
    Grenoble, 38700, France
    Recruiting
  • CH de Versailles
    Le Chesnay, 78150, France
    Recruiting
  • Service de Génétique moléculaire, pharmacogénétique, hormologie Hôpital Bicêtre
    Le Kremlin-Bicêtre, 94270, France
    • Andoni ECHANIZ-LAGUNA, MD · Contact · 0033145212121
    Recruiting
  • Hospices Civils de Lyon
    Lyon, 69317, France
    Recruiting
  • CHU Marseille
    Marseille, 13005, France
    • Nathalie BONELLO, MD · Contact
    Recruiting
  • CHU de Nantes
    Nantes, 44000, France
    Recruiting
  • CH Pitié Salpêtrière
    Paris, 75013, France
    Recruiting
  • Hôpital Necker
    Paris, 75015, France
    Recruiting
  • CHU de Saint-Etienne
    Saint-Etienne, 42270, France
    Recruiting
  • CHU Strasbourg
    Strasbourg, 67000, France
    • Aleksandra NADAJ PAKLEZA · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07038239
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jun 26, 2025
Start date
Jun 16, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jun 18, 2026

Study contacts

Shams RIBAULT, MD
Contact
shams.ribault@chu-lyon.fr
00334 72 07 25 73

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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