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CompletedNCT01984957TRANEUpdated Mar 23, 2015

Differential Study of Muscle Transcriptome

An interventional study of Muscle biopsy in ALS, SMA and SBMA, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-03-23.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To isolate biomarkers of ALS in muscle

Read the detailed description

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)

02

Conditions studied

  • ALS
  • SMA
  • SBMA

Keywords

  • ALS
  • Motor neuron diseases
  • Transcriptome
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient with ALS, SMA, or SBMA

Exclusion criteria

Exclusion criteria :

  • Indication against biopsy (allergy to anesthetics local haemostasis disorders)
  • Treatments that can affect muscle metabolism
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Other
    disease (ALS, SMA or SBMA)

    muscle biopsy

    Procedure: Muscle biopsy

Interventions

  • ProcedureMuscle biopsy

    open muscular biopsy of the deltoid under local anaesthesia

06

What researchers measure

Primary outcomes

  1. Gene expression levels

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

    Time frame: day 1

Secondary outcomes

  1. muscle denervation

    Severity of muscle denervation as determined by histological analysis of muscle

    Time frame: day 1

  2. Functional evaluation

    ALSFRS-R, Manual Muscle Testing and Slow Vital Capacity

    Time frame: day 1

07

Study locations

1 site
  • Centre d'évaluation Thérapeutique, Dr LACOMBLEZ
    Paris, 75013, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01984957
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Direction Générale de l'Offre de Soins, Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Nov 15, 2013
Start date
Jan 2013
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Mar 23, 2015

Study contacts

Pierre-Francois Pradat, MD, PhD
principal investigator · APHP

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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