Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT04670705
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2020-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship of CP and AP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050500', 'term': 'Pancreatitis, Chronic'}, {'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1022}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2020-12-11', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the occurrence of acute pancreatitis', 'timeFrame': 'Baseline (before the diagnosis of CP)', 'description': 'the presence and frequency of acute pancreatitis before diagnosis of CP'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pancreatitis', 'Acute Pancreatitis']}, 'descriptionModule': {'briefSummary': 'The present study aimed to determine the prevalence of AP attacks before the diagnosis of CP and further identified the potential associated factors for AP episodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consequent patients with a diagnosis of CP were enrolled between January 2010 to December 2015 after informed consents obtained.The diagnosis of CP was established based on the findings of computed tomography, magnetic resonance imaging, or endoscopic ultrasound, in accordance with the Asia-Pacific consensus.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consequent patients with a diagnosis of CP between January 2010 to December 2015\n* informed consents provided\n\nExclusion Criteria:\n\n* autoimmune pancreatitis (AIP)\n* pancreatic cancer diagnosed within 2 years after the diagnosis of CP'}, 'identificationModule': {'nctId': 'NCT04670705', 'briefTitle': 'Relationship of CP and AP', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'The Prevalence of Acute Pancreatitis Episodes Among Patients With Chronic Pancreatitis and the Associated Factors', 'orgStudyIdInfo': {'id': 'AP&CP'}}, 'armsInterventionsModule': {'interventions': [{'name': "patients' characteristics", 'type': 'OTHER', 'description': 'There was no intervention.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhuan Liao', 'investigatorAffiliation': 'Changhai Hospital'}}}}