Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-30 @ 4:45 PM
Study NCT ID:
NCT01728103
Status:
TERMINATED
Last Update Posted:
2017-08-16
First Post:
2012-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002690', 'term': 'Chlamydia Infections'}, {'id': 'D006069', 'term': 'Gonorrhea'}, {'id': 'D014245', 'term': 'Trichomonas Infections'}], 'ancestors': [{'id': 'D002694', 'term': 'Chlamydiaceae 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'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'urine; endocervical and vaginal swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1336}}, 'statusModule': {'whyStopped': 'Corporate decision to spend money on other development programs.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'lastUpdateSubmitDate': '2017-08-14', 'studyFirstSubmitDate': '2012-11-12', 'studyFirstSubmitQcDate': '2012-11-13', 'lastUpdatePostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease', 'timeFrame': 'approximately one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chlamydia Infections', 'Gonorrhea', 'Trichomonas Infections']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female subjects at least 16 years of age, with or without symptoms of sexually transmitted disease.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had penile/vaginal intercourse within the past 12 months)\n* The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board \\[IRB\\]-approved waiver for parental consent for minors)\n\nIn addition, the subject must meet at least one of the following criteria:\n\n* The subject reports symptoms consistent with a suspected sexually transmissible infection (STI) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort\n* Subject is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI(s)\n* Subject is asymptomatic and undergoing screening evaluation for possible STIs\n* Subject is asymptomatic and undergoing a routine examination with a pelvic examination\n\nExclusion Criteria:\n\n* The subject took antibiotic medications within the last 21 days\n* Subject already participated in this study\n* Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial\n* Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled'}, 'identificationModule': {'nctId': 'NCT01728103', 'briefTitle': 'Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gen-Probe, Incorporated'}, 'officialTitle': 'Prospective Collection of Female First-catch Urine, Vaginal Swab,Cervical, and Endocervical Swab Specimens for Testing With the APTIMA Assays', 'orgStudyIdInfo': {'id': 'ATVTS-US12-001'}, 'secondaryIdInfos': [{'id': 'AC2PS-US12-002', 'type': 'OTHER', 'domain': 'Gen-Probe'}, {'id': 'ATVPS-US12-001', 'type': 'OTHER', 'domain': 'Gen-Probe'}, {'id': 'ATVTS-US12-003', 'type': 'OTHER', 'domain': 'Gen-Probe'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Treatment', 'interventionNames': ['Device: APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays']}], 'interventions': [{'name': 'APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays', 'type': 'DEVICE', 'description': 'In Vitro Diagnostic Assays', 'armGroupLabels': ['No Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Infectious Diseases STD Program University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Healthcare Clinical Data', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '30328', 'city': 'Sandy Springs', 'state': 'Georgia', 'country': 'United States', 'facility': 'Mount Vernon Clinical Research', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'John Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02720', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Center for Clinical Research', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '27599-7030', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Planned Parenthood Southeastern Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Jackson Clinic', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '77023', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Planned Parenthood Gulf Coast', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Tidewater Clinical Research', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Renee Wait', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gen-Probe, Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gen-Probe, Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}