Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-01 @ 10:42 AM
Study NCT ID:
NCT03997669
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2019-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Diagnosis and Mechanism of Pleural Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010995', 'term': 'Pleural Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The blood and pleural effusions if there is any, will be collected and detected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2019-06-22', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '1 years', 'description': 'the percentage of people in a group who are alive after a year for malignant pleural effusion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pleural Diseases']}, 'descriptionModule': {'briefSummary': 'The diagnosis, treatment and mechanism of pleural diseases', 'detailedDescription': 'The diagnosis and treatment of benign and malignant pleural effusions, the mechanisms of pleural diseases'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with pleural effusion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with pleural effusion, who has not been treated\n\nExclusion Criteria:\n\nPatients with pleural effusion, who has already been treated'}, 'identificationModule': {'nctId': 'NCT03997669', 'briefTitle': 'The Diagnosis and Mechanism of Pleural Effusion', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'The Diagnosis and Mechanism of Pleural Effusion', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'experimental group', 'description': 'patients with malignant pleural effusion', 'interventionNames': ['Other: Collection of pleural effusion']}, {'label': 'control group', 'description': 'patients with benign pleural effusion', 'interventionNames': ['Other: Collection of pleural effusion']}], 'interventions': [{'name': 'Collection of pleural effusion', 'type': 'OTHER', 'description': 'Detection of pleural effusion', 'armGroupLabels': ['control group', 'experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'State...', 'country': 'China', 'facility': 'Jinshuo Fan', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Jinshuo Fan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Key Laboratory of Respiratory Diseases of the Ministry of Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yang Jin', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}