Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-03-27 @ 12:36 PM
Study NCT ID:
NCT02926261
Status:
UNKNOWN
Last Update Posted:
2020-02-28
First Post:
2016-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methods for Nutritional Assessment in Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum and plasma samples collected at time of evaluation and stored at -80°.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-27', 'studyFirstSubmitDate': '2016-10-05', 'studyFirstSubmitQcDate': '2016-10-05', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutritional status', 'timeFrame': 'Evaluation at time of recruitment', 'description': 'Characterization of nutritional status by three methods of nutritional assessment\n\n* Bioelectrical impedance vector analysis\n* CT scan\n* Handgrip strength'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Liver Cirrhosis', 'Cachexia', 'Malnutrition']}, 'descriptionModule': {'briefSummary': 'Nutritional status in patients with cirrhosis has been shown to have a direct influence on the prognosis of these patients, it is related to higher mortality and it has been linked to the developement and perpetuation of certain complications such as hepatic encephalopathy, ascites and spontaneous bacterial peritonitis.\n\nDespite the importance of nutritional status in this patients, most of the methods for its assessment are still not completely reliable or not easily accessible; therefore, evaluating nutritional status in the daily clinical practice is still a complex task.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cohort of patients with cirrhosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cirrhosis\n* No restriction of etiology\n* 18-75 years\n* Child-Pugh stage A/B/C\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Extremity amputation\n* Malignancy different from hepatocellular carcinoma'}, 'identificationModule': {'nctId': 'NCT02926261', 'briefTitle': 'Methods for Nutritional Assessment in Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, 'officialTitle': 'Evaluation of Three Methods for Nutritional Assessment in Patients With Cirrhosis', 'orgStudyIdInfo': {'id': 'BIVA0978'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bioelectrical impedance vector analysis', 'type': 'OTHER', 'description': 'Evaluation of nutritional status with Bioelectrical impedance vector analysis, hand-grip strength and computed-tomography scan'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'state': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Aldo Torre Delgadillo, BSc, MSc', 'role': 'CONTACT', 'email': 'detoal@yahoo.mx', 'phoneExt': '2711'}], 'facility': 'Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Aldo Torre, MD, MSc', 'role': 'CONTACT', 'email': 'detoal@yahoo.com', 'phone': '5554870900', 'phoneExt': '2711'}], 'overallOfficials': [{'name': 'Aldo Torre, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc', 'investigatorFullName': 'ALDO TORRE DELGADILLO', 'investigatorAffiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}}}}