Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT03001934
Status:
RECRUITING
Last Update Posted:
2020-10-22
First Post:
2016-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Super Chinese Nephrotic Syndrome Registration System (SUCCESS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009404', 'term': 'Nephrotic Syndrome'}], 'ancestors': [{'id': 'D009401', 'term': 'Nephrosis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The serum, urine, DNA and renal tissue will be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2016-12-21', 'studyFirstSubmitQcDate': '2016-12-21', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The patient survival in NS patients', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'Renal survival in NS patients', 'timeFrame': '10 years', 'description': 'Renal survival including end stage renal disease, dialysis, renal transplantation'}, {'measure': 'Longitudinal changes of renal function of NS patients', 'timeFrame': '10 years'}, {'measure': 'Treatment response of NS patients', 'timeFrame': '10 years'}, {'measure': 'Infection rate of NS patients', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nephrotic syndrome', 'Treatment response', 'Renal function'], 'conditions': ['Nephrotic Syndrome']}, 'descriptionModule': {'briefSummary': 'The investigators are registering all nephrotic syndrome (NS) patients regardless of the primary causes and developing a NS database in China. Patients will be followed-up and both baseline and follow-up information will be recorded in the registration system. The treatment response, longitudinal changes of renal function, renal survival, patient survival, infection events and acute kidney injury etc, will be analyzed using the NS database.', 'detailedDescription': "The investigators are registering all NS patients regardless of the primary causes in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education), clinical characteristics (including systolic blood pressure, diastolic blood pressure, primary cause of NS, and lab measurements of serum, urine), pathological characteristics, treatment and treatment response, complications and outcomes. Patients will be followed up, the demographic, clinical characteristics, treatment, lab tests of blood and urine and complications of patients will be collected and recorded at each visit. The investigators also record the outcome at each visit, such as treatment response, longitudinal changes of renal function, hospitalization, occurrence of infection or cardiovascular events etc. The outcomes will be analyzed using the NS database."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Nephrotic syndrome patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nephrotic syndrome patients regardless of the primary causes\n\nExclusion Criteria:\n\n* No'}, 'identificationModule': {'nctId': 'NCT03001934', 'briefTitle': 'Super Chinese Nephrotic Syndrome Registration System (SUCCESS)', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Super Chinese Nephrotic Syndrome Registration System (SUCCESS)', 'orgStudyIdInfo': {'id': 'SUCCESS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nephrotic syndrome patients', 'description': 'Patients diagnosis as nephrotic syndrome (NS)', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Registration of all NS patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals which have signed the contract in China.', 'armGroupLabels': ['Nephrotic syndrome patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xueqing Yu, M.D. & Ph.D.', 'role': 'CONTACT', 'email': 'yuxq@mail.sysu.edu.cn'}, {'name': 'Xueqing Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The 1st Affiliated Hospital, Sun Yet-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xueqing Yu, M.D. & Ph.D', 'role': 'CONTACT', 'email': 'yuxq@mail.sysu.edu.cn'}, {'name': 'Naya Huang, M.D. & Ph.D', 'role': 'CONTACT', 'email': 'huangnaya@163.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xue Qing Yu', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}