Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT00337402
Status:
COMPLETED
Last Update Posted:
2006-11-22
First Post:
2006-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Gastrostomy on Amyotrophic Lateral Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-06', 'completionDateStruct': {'date': '2005-06'}, 'lastUpdateSubmitDate': '2006-11-20', 'studyFirstSubmitDate': '2006-06-15', 'studyFirstSubmitQcDate': '2006-06-15', 'lastUpdatePostDateStruct': {'date': '2006-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-16', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Gastrostomy', 'Quality of life'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients. Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France (observational study)', 'detailedDescription': 'Following data have been recorded each three months: QoL (MOS-SF 36 and ALSAQ), bodily mass index, testing and ALS-FRS scale, functional respiratory measures, impedance analysis, and the time for tube feeding procedure, the conditions of the acceptance and side-effects of gastrotomy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients \\> 18 years-old\n* ALS certain or probable\n* vital capacity (respiratory) \\> 70 %\n* under riluzole\n\nExclusion Criteria:\n\n* ALS in family\n* other conditions affected survival and QoL\n* cognitive impairment'}, 'identificationModule': {'nctId': 'NCT00337402', 'briefTitle': 'Effects of Gastrostomy on Amyotrophic Lateral Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Effects of Gastrostomy on Quality of Life and Survival in Patients With Amyotrophic Lateral Sclerosis', 'orgStudyIdInfo': {'id': 'CHU63-0001'}}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Clermont-Ferrand University Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Pierre Clavelou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, {'name': 'University Hospital, Caen', 'class': 'OTHER'}, {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, {'name': 'University Hospital, Lille', 'class': 'OTHER'}, {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, {'name': 'Neurological department of Lyon University Hospital', 'class': 'UNKNOWN'}, {'name': 'University Hospital, Marseille', 'class': 'OTHER'}, {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, {'name': 'University Hospital, Paris', 'class': 'OTHER'}, {'name': 'University Hospital, Strasbourg', 'class': 'OTHER'}, {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, {'name': 'University Hospital, Tours', 'class': 'OTHER'}]}}}