Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
Study NCT ID:
NCT03970850
Status:
COMPLETED
Last Update Posted:
2020-06-12
First Post:
2019-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NeuMoDx PrEDiCTiNG Study Evaluation Plan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006069', 'term': 'Gonorrhea'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4017}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-11', 'studyFirstSubmitDate': '2019-05-30', 'studyFirstSubmitQcDate': '2019-05-30', 'lastUpdatePostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical specificity and sensitivity', 'timeFrame': 'Through study completion, an average of 1 year', 'description': "Clinical specificity and sensitivity of NeuMoDx CT/NG Assay for both CT and NG relative to an individual's patient infected status (PIS)"}], 'secondaryOutcomes': [{'measure': 'Valid results rate', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Evaluate indeterminate and unresolved rates'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chlamydia Trachomatis Infection', 'Neisseria Gonorrheae Infection']}, 'descriptionModule': {'briefSummary': 'This investigational study will be conducted to evaluate the performance of the NeuMoDx™ CT/NG Assay on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System (collectively referred to as NeuMoDx™ CT/NG Assay test system).', 'detailedDescription': "Clinical performance characteristics of the NeuMoDx CT/NG Assay on NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System will be evaluated in a multi-center, prospective, sampling study by comparing the diagnoses made by the NeuMoDx™ CT/NG Assay to Patient Infected Status (PIS) as the reference standard.\n\nProspectively collected urine and swab specimens from individual subjects will be tested using the NeuMoDx™ CT/NG Assay at one of the three NeuMoDx testing sites. Subjects' PIS for CT and PIS for NG will be determined by a central laboratory using FDA-cleared, legally marketed CT/NG combo assays on pre-specified sample matrices according to the PIS determination algorithms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '14 Years', 'genderBased': True, 'genderDescription': 'Subjects eligible for CT/NG screening (make sure it matches the protocol)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female subjects of at least 14 years of age or older.\n2. Subject must be able and willing to provide informed consent. The use of a 'surrogate' or 'Legally Authorized Representative' is allowed and shall follow the site's standard procedures, under which the clinical investigation will be conducted.\n3. Subjects undergoing a routine pelvic examination, subjects eligible for screening evaluations for possible STDs and/or subjects known to be partners with a person with a confirmed or suspected STD.\n4. Subject is willing to provide all required specimens.\n\nExclusion Criteria:\n\n1. Female subject reports that she had a hysterectomy.\n2. Subject self-reports use of antibiotics within 28 days of study enrollment."}, 'identificationModule': {'nctId': 'NCT03970850', 'briefTitle': 'NeuMoDx PrEDiCTiNG Study Evaluation Plan', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeuMoDx Molecular, Inc.'}, 'officialTitle': 'Multi-Center Clinical Performance Evaluation of the NeuMoDx™ Chlamydia Trachomatis (CT) / Neisseria Gonorrhoeae (NG) [CT/NG] Assay on the NeuMoDx™ 288 Molecular System and the NeuMoDx™96 Molecular System', 'orgStudyIdInfo': {'id': 'CTNG-01-18NMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Multi-arm - Symptomatic and Asymptomatic Males', 'description': 'Arm 1 - Urine from males subjects', 'interventionNames': ['Diagnostic Test: NeuMoDx CT/NG Assay']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multi-arm - Symptomatic and Asymptomatic Females', 'description': 'Arm 2 - Endocervical, self-collected (in the clinical setting) and physician-collected vaginal swabs and urine from female subjects', 'interventionNames': ['Diagnostic Test: NeuMoDx CT/NG Assay']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multi-arm - FDA cleared NAATs (Comparator)', 'description': 'Arm 3 - Comparator (for females - vaginal and urine NAATs and for males - 3 urine NAATs)', 'interventionNames': ['Diagnostic Test: FDA-cleared NAATs']}], 'interventions': [{'name': 'NeuMoDx CT/NG Assay', 'type': 'DIAGNOSTIC_TEST', 'description': 'NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System', 'armGroupLabels': ['Multi-arm - Symptomatic and Asymptomatic Females', 'Multi-arm - Symptomatic and Asymptomatic Males']}, {'name': 'FDA-cleared NAATs', 'type': 'DIAGNOSTIC_TEST', 'description': 'Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs', 'armGroupLabels': ['Multi-arm - FDA cleared NAATs (Comparator)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Healthcare Clinical Date, Inc. (Segal Trials)', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '32817', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Planned Parenthood - Southwest and Central Florida', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33617', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Planned Parenthood - Southwest and Central Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University (IU)', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Health Science', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48108', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'NeuMoDx Molecular, Inc.', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System (HFHS)', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '07201', 'city': 'Elizabeth', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Planned Parenthood - Northern, Central and Southern New Jersey', 'geoPoint': {'lat': 40.66399, 'lon': -74.2107}}, {'zip': '07860', 'city': 'Newton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Planned Parenthood - Northern, Central and Southern New Jersey', 'geoPoint': {'lat': 41.05815, 'lon': -74.75267}}, {'zip': '08075', 'city': 'Riverside Park', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Planned Parenthood - Northern, Central and Southern New Jersey', 'geoPoint': {'lat': 40.03844, 'lon': -74.97461}}, {'zip': '87505', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'TriCore Reference Labs', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina (MUSC)', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77023', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Planned Parenthood - Gulf Coast', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeuMoDx Molecular, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'NAMSA', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}