Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT04074369
Status:
UNKNOWN
Last Update Posted:
2019-08-30
First Post:
2019-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of CRISPR-based Test for the Rapid Identification of TB in Pulmonary Tuberculosis Suspects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'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': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-28', 'studyFirstSubmitDate': '2019-08-28', 'studyFirstSubmitQcDate': '2019-08-28', 'lastUpdatePostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay positive and/or MGIT culture positive for M.tuberculosis.', 'timeFrame': 'week 0'}, {'measure': 'Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay negative and/or MGIT culture negative for M.tuberculosis.', 'timeFrame': 'week 0'}, {'measure': 'Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF.', 'timeFrame': 'week 0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tuberculosis, Pulmonary']}, 'referencesModule': {'references': [{'pmid': '33616229', 'type': 'DERIVED', 'citation': 'Zifodya JS, Kreniske JS, Schiller I, Kohli M, Dendukuri N, Schumacher SG, Ochodo EA, Haraka F, Zwerling AA, Pai M, Steingart KR, Horne DJ. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. Cochrane Database Syst Rev. 2021 Feb 22;2(2):CD009593. doi: 10.1002/14651858.CD009593.pub5.'}]}, 'descriptionModule': {'briefSummary': 'This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a prospective study of pulmonary TB suspects who are undergoing sputum or bronchoalveolar lavage fluid (BALF) evaluation for pulmonary TB. The sensitivity and specificity of the CRISPR-based assay will be compared to clinical diagnosis, conventional culture methods and Xpert MTB/RIF assay on same batch specimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Suspected pulmonary TB patients in Huashan Hospital, Wenzhou Central Hospital and Hangzhou Red Cross Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected pulmonary TB.\n* Ability and willingness of candidate or legal guardian/representative to provide informed consent.\n* Men and women age equal to or greater than 18 years.\n\nExclusion Criteria:\n\n* Either receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment within 180 days prior to completion of second sputum collection for Xpert testing'}, 'identificationModule': {'nctId': 'NCT04074369', 'briefTitle': 'Evaluation of CRISPR-based Test for the Rapid Identification of TB in Pulmonary Tuberculosis Suspects', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'Evaluation of CRISPR-based Test for the Rapid Identification of Mycobacterium Tuberculosis Complex in Pulmonary Tuberculosis Suspects', 'orgStudyIdInfo': {'id': '20190601'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonary Tuberculosis Suspects', 'description': 'Individuals with suspected TB infection', 'interventionNames': ['Diagnostic Test: CRISPR-based Test']}], 'interventions': [{'name': 'CRISPR-based Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'CRISPR-based Test performed on sputum or BALF in TB suspects.', 'armGroupLabels': ['Pulmonary Tuberculosis Suspects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing-wen Ai', 'role': 'CONTACT', 'email': 'jingwenai1990@126.com', 'phone': '(+86) 21 5288 7970'}, {'name': 'Xian Zhou', 'role': 'CONTACT', 'email': 'zhouxianhz@gmail.com', 'phone': '(+86) 21 5288 7970', 'phoneExt': 'Zhou'}], 'facility': 'Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wenhong Zhang', 'role': 'CONTACT', 'email': 'zhangwenhong@fudan.edu.cn', 'phone': '(+86) 21 5288 7970'}, {'name': 'Jingwen Ai', 'role': 'CONTACT', 'email': 'jingwenai1990@126.com', 'phone': '(+86) 21 5288 7970'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wenzhou Central Hospital', 'class': 'OTHER'}, {'name': 'Red Cross Hospital, Hangzhou, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Division of Infectious Diseases', 'investigatorFullName': 'Wen-hong Zhang', 'investigatorAffiliation': 'Huashan Hospital'}}}}