Differential Study of Muscle Transcriptome

NCT ID: NCT01984957

Last Updated: 2015-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-01-31

Brief Summary

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To isolate biomarkers of ALS in muscle

Detailed Description

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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)

Conditions

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ALS SMA SBMA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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disease (ALS, SMA or SBMA)

muscle biopsy

Group Type OTHER

Muscle biopsy

Intervention Type PROCEDURE

open muscular biopsy of the deltoid under local anaesthesia

Interventions

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Muscle biopsy

open muscular biopsy of the deltoid under local anaesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Direction Générale de l'Offre de Soins

OTHER_GOV

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-Francois Pradat, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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Centre d'évaluation Thérapeutique, Dr LACOMBLEZ

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P110401

Identifier Type: -

Identifier Source: org_study_id

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