Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT06516367
Status:
COMPLETED
Last Update Posted:
2024-07-23
First Post:
2024-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening Tool for Malnutrition, Sarcopenia, and Cachexia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D002100', 'term': 'Cachexia'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D013851', 'term': 'Thinness'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-07-03', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reliability of a new tool for the simultaneous screening of muscle wasting diseases in older adults', 'timeFrame': '10 months', 'description': "Relaibility; Cronbach's alpha coefficient was used to evaluate the internal consistency."}, {'measure': 'validity of a new tool for the simultaneous screening of muscle wasting diseases in older adults', 'timeFrame': '10 months', 'description': "Validity; Spearman's correlation coefficient was used to examine construct validity of the new tool"}], 'secondaryOutcomes': [{'measure': 'The diagnostic accuracy of the new tool', 'timeFrame': '10 months', 'description': 'The Receiver operating curve was plotted to detect the area under curve of the new tool, for diagnosing muscle wasting diseases.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['screening', 'older adult', 'malnutrition', 'cachexia', 'sarcopenia'], 'conditions': ['Malnutrition', 'Sarcopenia', 'Cachexia']}, 'descriptionModule': {'briefSummary': 'There is an accumulating evidence of the overlap and frequent co-occurrence of twasting conditions in older adults. Those conditions include malnutrition, sarcopenia, and cachexia, Therefore , a tool capable of simultaneously screening for all three conditions is imperative. In this study, we developed and validated a new tool for the simultaneous screening of muscle wasting diseases in older adults. The diagnostic accuracy of the new tool was compared to other validated screening tools including the Mini Nutritional Assessment-Short Form (MNA-SF), the Short Nutritional Assessment Questionnaire (SNAQ), and the Simple Questionnaire to Rapidly Diagnose Sarcopenia (SARC-F).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '300 older participants aged 60 years old and above who were admitted to Ain Shams University Hospitals or interviewed at the hospital clinic', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants Aged 65 years and older, who agree to participate\n\nExclusion Criteria:\n\n* Patients with critical illness.\n* Patients with severe cognitive, hearing or visual impairment hindering proper communication\n* Patients with physical disability that interfere with physical performance assessment or hand grip measurement\n* Patient with any contraindication of to the use of BIA) e.g. presence of a pacemaker, other implanted electrical devices, or metal implants, volume overload'}, 'identificationModule': {'nctId': 'NCT06516367', 'acronym': 'ASUST-MSC', 'briefTitle': 'Screening Tool for Malnutrition, Sarcopenia, and Cachexia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Development and Validation of a New Tool for Simultaneous Screening of Malnutrition, Sarcopenia, and Cachexia in Older Adults', 'orgStudyIdInfo': {'id': 'Ain Shams Screening tools'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ain Shams University Screening Tool for Malnutrition, Sarcopenia, and Cachexia (ASUST-MSC)', 'type': 'OTHER', 'otherNames': ['bioelectrical impedence analysis', 'handheld dynamometer'], 'description': '25 items dichotomous questionnaire'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Geriatrics and Gerontology', 'investigatorFullName': 'Doha Rasheedy', 'investigatorAffiliation': 'Ain Shams University'}}}}