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OpenTrials
Completed

NCT Number: NCT01984957

Differential Study of Muscle Transcriptome

To isolate biomarkers of ALS in muscle

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Key information

Conditions

ALS Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases SBMA SMA

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'évaluation Thérapeutique, Dr LACOMBLEZ

Paris, 75013, France

About this study

At present, there is no validated biological diagnostic marker for amyotrophic lateral sclerosis (ALS). The main objective of the study is to isolate a set of genes that are specifically dysregulated in muscle from ALS patients.

Gene profiling in muscle will be compared between ALS patients and patients with other motor neuron diseases (SMA and SBMA)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with ALS, SMA, or SBMA

Exclusion criteria

  • Indication against biopsy (allergy to anesthetics local haemostasis disorders)
  • Treatments that can affect muscle metabolism

Treatment and study plan

Muscle biopsy

Procedure

open muscular biopsy of the deltoid under local anaesthesia

Primary outcomes

  1. Gene expression levels

    Time frame: day 1

    Gene expression levels in muscle as determined By microarrays (transcriptome analysis)

Secondary outcomes

  1. muscle denervation

    Time frame: day 1

    Severity of muscle denervation as determined by histological analysis of muscle

  2. Functional evaluation

    Time frame: day 1

    ALSFRS-R, Manual Muscle Testing and Slow Vital Capacity

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Direction Générale de l'Offre de Soins
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Differential Study of Muscle Transcriptome in Patients With Neuromuscular Disease and Control Subjects

Acronym: TRANE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 15, 2013
Registry last updated
Mar 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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