Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-25 @ 4:40 PM
Study NCT ID:
NCT02175134
Status:
TERMINATED
Last Update Posted:
2018-08-29
First Post:
2014-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D010538', 'term': 'Peritonitis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'low enrollment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2014-06-25', 'studyFirstSubmitQcDate': '2014-06-25', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the frequency of laparoscopic biopsy', 'timeFrame': '1 week after the enrollment'}], 'secondaryOutcomes': [{'measure': 'the frequency of correct or wrong diagnosis', 'timeFrame': '6 months after the enrollment', 'description': 'the frequency of correct or wrong diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tuberculosis', 'peritonitis', 'laparoscopy'], 'conditions': ['Suspected Tuberculous Peritonitis']}, 'descriptionModule': {'briefSummary': "The diagnosis of tuberculous peritonitis (TBP) is still challenging, and largely dependent on invasive procedures such as laparoscopy. A recently developed RD-1 gene-based assay for diagnosing TBP shows has given promising results. The investigators thus created a 2-step algorithm using the Blood/Ascites ELISPOT assays and adenosine deaminase (ADA) in ascites for differentiation of TBP from other diagnoses (Blood ELISPOT ≥6 spots or ADA ≥ 21 U/L' as a rule-out test and 'Ascites/Blood ratio ≥3' as a rule-in test). This study is the randomized controlled trial on whether this 2-step algorithm-based approach can reduce the laparoscopic biopsy for the diagnosis of TBP in patients with suspected TBP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients with suspected tuberculous peritonitis\n* age 16 or more\n* formal informed consent\n\nExclusion Criteria:\n\n* not specified'}, 'identificationModule': {'nctId': 'NCT02175134', 'briefTitle': 'IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis', 'orgStudyIdInfo': {'id': '2014-0616'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'conventional diagnostic flow arm', 'description': "Perform the laparoscopic biopsy as a discretion of attending physician's decision"}, {'type': 'EXPERIMENTAL', 'label': 'two-step algorithm-based approach', 'description': "Perform the laparoscopic biopsy as a discretion of attending physician's decision, but if the below conditions are met, do not perform the laparoscopic biopsy.\n\n1. Blood ELISPOT \\>= 6 spots or ascites adenosine deaminase \\> 20 IU/L, and\n2. Ascites ELISPOT/Blood ELISPOT rato \\> 3", 'interventionNames': ['Other: Blood and Ascites ELISPOT']}], 'interventions': [{'name': 'Blood and Ascites ELISPOT', 'type': 'OTHER', 'armGroupLabels': ['two-step algorithm-based approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sung-Han Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sung-Han Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}