Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07332702

Long Read Analysis in Spinal Muscular Atrophy - LOREASI

Led by University Hospital, Rouen · Updated on 2026-01-12

27

Participants Needed

1

Research Sites

87 weeks

Total Duration

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Sponsors

U

University Hospital, Rouen

Lead Sponsor

A

Agence de La Biomédecine

Collaborating Sponsor

AI-Summary

What this Trial Is About

Spinal Muscular Atrophy (SMA) is a severe neuromuscular disease caused by deletion of the SMN1 gene, with the most severe form leading to death in children without treatment. Genetic counselling to detect couples where both partners are carriers is particularly important. In some countries, preconception screening is offered. However, some carriers escape detection due to the existence of two copies of the SMN1 gene side-by-side (2+0 genotype). Currently, no molecular genetic methods used for diagnostic purposes can detect these 2+0 genotypes, which pose a significant challenge in genetic counselling. This study aims to use new technologies based on the analysis of ultra-long molecules to detect side-by-side duplications of the SMN1 gene to detect heterozygous subjects not identified by current techniques and improve genetic counselling.

CONDITIONS

Official Title

Long Read Analysis in Spinal Muscular Atrophy - LOREASI

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult aged 18 years or older
  • Has either 1 or 3 copies of the SMN1 gene (control group) or 2 copies of the SMN1 gene in cis (2+0 genotype) (test group)
  • Affiliated to French health insurance
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Individuals deprived of liberty by administrative or judicial decision
  • Individuals under guardianship or curatorship

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Rouen

Rouen, France

Actively Recruiting

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Research Team

P

Pascale Saugier-Veber, PharmD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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