Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
Study NCT ID:
NCT06720766
Status:
RECRUITING
Last Update Posted:
2024-12-06
First Post:
2024-11-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Estimated using the area under the receiver operating characteristic curves for the categories of steatosis and fibrosis'}, {'measure': 'Cut-off values', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Optimal thresholds for application on people with obesity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'The non-invasive evaluation of liver steatosis and fibrosis with FibroScan is a routinely procedure in clinical practice for people with obesity. However, there are still considerable uncertainties regarding the potential influence of confounding factors and the optimal application of cut-off values for obesity.\n\nThe goal of this observational study is to learn about the optimal application of cut-off values of for Chinese people with obesity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of patients aged 18 years or older who provided written informed consent and were scheduled to undergo bariatric surgery.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18 years or older who provided written informed consent\n2. Patients who schedule to undergo bariatric surgery and a liver biopsy (LB) for the investigation of suspected MASLD\n3. Patients who schedule to undergo FibroScan examination\n\nExclusion Criteria:\n\n1. Patients with ascites or pregnant women\n2. Patients with any active implantable medical device (such as a pacemaker or defibrillator)\n3. Patients who have undergone liver transplantation\n4. Patients with cardiac failure and/or significant valvular disease\n5. Patients with haemochromatosis\n6. Patients who have refused to undergo LB or blood tests\n7. Patients with a confirmed diagnosis of active malignancy, or other terminal disease\n8. Patients participating in another clinical trial within the preceding 30 days'}, 'identificationModule': {'nctId': 'NCT06720766', 'acronym': 'MASLD', 'briefTitle': 'Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity', 'organization': {'class': 'OTHER', 'fullName': "The Third People's Hospital of Chengdu"}, 'officialTitle': 'Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity', 'orgStudyIdInfo': {'id': '2023-S-177'}, 'secondaryIdInfos': [{'id': 'CSY-YNXM-2023-001', 'type': 'OTHER_GRANT', 'domain': "The Third People's Hospital of Chengdu"}]}, 'armsInterventionsModule': {'interventions': [{'name': 'FibbroScan and biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'In individuals with obesity, a biopsy is performed within a week after undergoing an FibroScan examination.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiahui Yu', 'role': 'CONTACT', 'email': 'dr_jiahuiyu@163.com'}], 'facility': "The Third People's Hospital of Chengdu", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Peisen Guo', 'role': 'CONTACT', 'email': 'peisenguo@163.com', 'phone': '+8615803838681'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "The Third People's Hospital of Chengdu", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Researcher', 'investigatorFullName': 'Hongmei Zhu', 'investigatorAffiliation': "The Third People's Hospital of Chengdu"}}}}