RecruitingNot ApplicableNCT05394506

Modifying Factors in Striated Muscle Laminopathies

Identification of Genetic Modifying Factors in Striated Muscle Laminopathies


Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Enrollment

40 participants

Start Date

Sep 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Mutations in the LMNA gene, which codes for lamins A and C, proteins of the nuclear lamina, are responsible for a wide spectrum of pathologies, including a group specifically affecting striated skeletal and cardiac muscles, with cardiac involvement being life-threatening. At the skeletal muscle level, a wide phenotypic spectrum has been described, ranging from severe forms of congenital muscular dystrophy to less severe forms of limb-girdle muscular dystrophy. The great clinical variability of striated muscle laminopathies, both inter- and intra-familial, can be observed in the age of onset, severity of signs and progression of muscle and heart involvement. To date, more than 400 LMNA mutations have been associated with striated muscle laminopathies (www.umd.be/LMNA/), highlighting strong clinical and genetic heterogeneity. A few recurrent mutations linked to a difference in severity have been identified. However, these genotype-phenotype relationships and the rare cases of digenism reported do not explain all the clinical variability of laminopathies. Therefore, there are probably other factors of severity than the causative mutation, called "modifier genes". Identification of such modifier genes has been initiated by studying a large family with significant clinical variability in the age of onset of muscle signs. A segregation analysis within this family identified 2 potential modifier loci. High-throughput sequencing restricted to these 2 regions according to phenotypic subgroups did not led to meaningful results so far. In addition, an international retrospective study of the natural history of early muscle laminopathies has allowed the investigators to highlight a strong inter-family clinical variability in patients carrying recurrent mutations. The investigators thus have strong preliminary data that could allow them to identify modifying genetic factors in a cohort of patients carrying a mutation in the LMNA gene. In order to identify these factors that modulate the clinical severity of laminopathies, the investigators wish to collect biological material (muscle and/or skin biopsies) from patients carrying a mutation in the LMNA gene. The study of this biological material using multi OMICs technics will allow the investigators to identify and functionally validate the action of these modifying genes. OMIICs is a set of techniques for characterising biological molecules using high-throughput approaches such as DNA sequencing, RNA sequencing and/or chromatin conformation (ATACseq...), proteins.


Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating the genetic and biological factors that affect how striated muscle laminopathy (a rare inherited muscle disease caused by mutations in the LMNA gene) progresses differently in different people. Participants will have a muscle or skin biopsy taken as part of the research. You may be eligible if: - You have a confirmed LMNA gene mutation causing laminopathy affecting the heart or skeletal muscles - You have symptoms such as muscle weakness or tendon tightening (with or without heart/lung involvement) - You are at least 2 years old - You are affiliated with the French social security system - You (or your legal guardian) can provide written informed consent You may NOT be eligible if: - You are pregnant or breastfeeding - You have a known allergy to latex, local anesthetics, or antiseptics - You are on anticoagulant medications (blood thinners) - You have a known bleeding disorder - You are an adult under legal protection measures (guardianship) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESkin Biopsy

The skin biopsy is performed in the consultation outclinic room. A local anaesthetic (anaesthetic patch to be applied to the skin) is required for this procedure. The skin biopsy is usually performed on the front of the forearm (but can be performed on the arm, thigh or leg). After disinfection, a fragment of 3 to 4 mm in diameter is removed with a biopsy-punch (single-use device). If necessary, a suture can be placed. Otherwise, the wound is covered with Steristrip and a sterile dressing. The skin sample, intended for a fibroblast culture, will be placed in a flask to be kept at room temperature. It will be labelled with specific labels and sent to the local biological resource centre.

PROCEDUREMuscle biopsy

The muscle biopsy is performed in a sterile room. A local anaesthetic is required for this procedure. After selecting the muscle from which the sample will be taken (usually from the deltoid muscle at the shoulder stump), placing a sterile field and disinfecting, a small incision is made in the skin until the selected muscle is exposed. A bundle of muscle fibres of approximately 1 cm x 0.5 cm is removed. The skin is then sutured and covered with a sterile dressing. The procedure takes about 30 minutes (including patient set-up). The muscle sample will be divided into 2 fragments, one for myoblast culture, the other for frozen tissue. The 2 vials will be labelled with specific labels and then sent to the local biological resource centre


Locations(8)

Centre de référence maladies neuromusculaires, Hôpital Femme Mère Enfant, CHU Lyon

Bron, Auvergne-Rhône-Alpes, France

Centre de référence maladies neuromusculaires, Institut de myologie, Hôpital Pitié-Salpêtrière

Paris, France, France

Service de Neuropédiatrie, Centre de Référence Maladies Neuromusculaires, CHU de Montpellier

Montpellier, Hérault, France

Service de Génétique médicale, CHU Rennes

Rennes, Ille-et-Vilaine, France

Laboratoire d'Explorations Fonctionnelles - Centre de Référence Maladies Neuromusculaires Rares, CHU Nantes

Nantes, Loire-Atlantique, France

Service de cardiologie & Service de Neurophysiologie - CHU de Rouen

Rouen, Normandy, France

Centre de référence pour les maladies cardiaques héréditaires

Paris, Paris, France

Service de Neurologie, Réanimation Pédiatriques, Hôpital Raymond Poincaré, Hôpitaux Universitaires, Paris-Ile-de-France-Ouest

Garches, Île-de-France Region, France

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NCT05394506


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