Differential Study of Muscle Transcriptome (TRANE)

March 20, 2015 updated by: Assistance Publique - Hôpitaux de Paris

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

To isolate biomarkers of ALS in muscle

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: disease (ALS, SMA or SBMA)
muscle biopsy
Procedure: Muscle biopsy
open muscular biopsy of the deltoid under local anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene expression levels
Time Frame: day 1
Gene expression levels in muscle as determined By microarrays (transcriptome analysis)
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle denervation
Time Frame: day 1
Severity of muscle denervation as determined by histological analysis of muscle
day 1
Functional evaluation
Time Frame: day 1
ALSFRS-R, Manual Muscle Testing and Slow Vital Capacity
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

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

Investigators

  • Principal Investigator: Pierre-Francois Pradat, MD, PhD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

June 27, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Estimate)

March 23, 2015

Last Update Submitted That Met QC Criteria

March 20, 2015

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P110401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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