Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-04-23 @ 7:37 AM
Study NCT ID:
NCT01984957
Status:
COMPLETED
Last Update Posted:
2015-03-23
First Post:
2013-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differential Study of Muscle Transcriptome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016472', 'term': 'Motor Neuron Disease'}], 'ancestors': [{'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-20', 'studyFirstSubmitDate': '2013-06-27', 'studyFirstSubmitQcDate': '2013-11-07', 'lastUpdatePostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gene expression levels', 'timeFrame': 'day 1', 'description': 'Gene expression levels in muscle as determined By microarrays (transcriptome analysis)'}], 'secondaryOutcomes': [{'measure': 'muscle denervation', 'timeFrame': 'day 1', 'description': 'Severity of muscle denervation as determined by histological analysis of muscle'}, {'measure': 'Functional evaluation', 'timeFrame': 'day 1', 'description': 'ALSFRS-R, Manual Muscle Testing and Slow Vital Capacity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ALS', 'Motor neuron diseases', 'Transcriptome'], 'conditions': ['ALS', 'SMA', 'SBMA']}, 'descriptionModule': {'briefSummary': 'To isolate biomarkers of ALS in muscle', 'detailedDescription': '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.\n\nGene profiling in muscle will be compared between ALS patients and patients with other motor neuron diseases (SMA and SBMA)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria :\n\n\\- Patient with ALS, SMA, or SBMA\n\nExclusion criteria :\n\n* Indication against biopsy (allergy to anesthetics local haemostasis disorders)\n* Treatments that can affect muscle metabolism'}, 'identificationModule': {'nctId': 'NCT01984957', 'acronym': 'TRANE', 'briefTitle': 'Differential Study of Muscle Transcriptome', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Differential Study of Muscle Transcriptome in Patients With Neuromuscular Disease and Control Subjects', 'orgStudyIdInfo': {'id': 'P110401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'disease (ALS, SMA or SBMA)', 'description': 'muscle biopsy', 'interventionNames': ['Procedure: Muscle biopsy']}], 'interventions': [{'name': 'Muscle biopsy', 'type': 'PROCEDURE', 'description': 'open muscular biopsy of the deltoid under local anaesthesia', 'armGroupLabels': ['disease (ALS, SMA or SBMA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': "Centre d'évaluation Thérapeutique, Dr LACOMBLEZ", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Pierre-Francois Pradat, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': "Direction Générale de l'Offre de Soins", 'class': 'OTHER_GOV'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}