Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-06 @ 7:41 PM
Study NCT ID:
NCT03125460
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2017-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 424}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2017-04-19', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison to histology for positive or suspicious cystoscopy', 'timeFrame': 'Baseline = Subject Enrollment', 'description': 'Comparison to histology for positive or suspicious cystoscopy'}, {'measure': 'Comparison to histology for positive or suspicious cystoscopy', 'timeFrame': 'Follow up = 12 months from Subject Enrollment (Baseline)', 'description': 'Comparison to histology for positive or suspicious cystoscopy'}], 'secondaryOutcomes': [{'measure': 'Comparison to UroVysion and urine cytology', 'timeFrame': 'Baseline = Subject Enrollment', 'description': 'Urovysion and urine cytology'}, {'measure': 'Comparison to UroVysion and urine cytology', 'timeFrame': 'Follow up = 12 months from Subject Enrollment (Baseline)', 'description': 'Urovysion and urine cytology'}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to establish the performance characteristics of an assay that detects the recurrence of bladder cancer in patients previously diagnosed with bladder cancer. The study is conducted at locations within and outside of the United States. Testing is performed on urine specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Urology clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is ≥ 40 years of age\n* Subject has provided documented informed consent as required by the reviewing IRB or EC. Experimental Bill of Rights will be documented for all subjects enrolled in applicable states.\n* Subject is considered disease positive within 12 months (365 days) of enrollment.\n* At the time of the enrollment visit, the subject is scheduled for a standard of care cystoscopy which will be completed within 3 days of providing a urine specimen.\n* Subject has agreed to provide at least 60 mL of voided urine for study purposes at the enrollment visit.\n* Subject has agreed to provide at least 60 mL of voided urine for study purposes at each subsequent standard of care cystoscopy visit for at least 12 months (365 days) following enrollment if the subject will enter the Longitudinal cohort.\n* Any subject considered anticipatory positive at the initial visit shall be enrolled into the longitudinal cohort. For each anticipatory positive enrolled into the longitudinal cohort a random disease negative subject shall be enrolled.\n\nExclusion\n\n* Subject has been previously enrolled into the study.\n* Urine specimen to be used for study purposes is from the first morning void.\n* Subject has had an excision procedure within six weeks (42 days) of enrollment.\n* The subject is not scheduled for a standard of care cystoscopy visit within 12 months (365 days) following enrollment.'}, 'identificationModule': {'nctId': 'NCT03125460', 'briefTitle': 'Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cepheid'}, 'officialTitle': 'Clinical Evaluation of Xpert Bladder Cancer Monitor for Monitoring the Recurrence of Bladder Cancer', 'orgStudyIdInfo': {'id': '170'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Initial Enrollment', 'description': 'Initial enrollment of patients with history of bladder cancer', 'interventionNames': ['Device: Xpert Bladder Cancer Monitor']}, {'label': 'Longitudinal Cohort', 'description': 'Longitudinal Cohort - patients considered anticipatory positive at the time of enrollment and one random disease negative patient per anticipatory positive patient', 'interventionNames': ['Device: Xpert Bladder Cancer Monitor']}], 'interventions': [{'name': 'Xpert Bladder Cancer Monitor', 'type': 'DEVICE', 'description': 'in vitro diagnostic test for the recurrence of bladder cancer in patients that have been previously diagnosed with bladder cancer', 'armGroupLabels': ['Initial Enrollment', 'Longitudinal Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'PAVA', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80211', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'The Urology Center of Colorado, P.C.', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Urology Associates, P.C.', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '83814', 'city': "Coeur d'Alene", 'state': 'Idaho', 'country': 'United States', 'facility': 'North Idaho Urology', 'geoPoint': {'lat': 47.67768, 'lon': -116.78047}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Idaho Urologic Institute', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '60160', 'city': 'Melrose Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'UroPartners', 'geoPoint': {'lat': 41.90059, 'lon': -87.85673}}, {'zip': '59808', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Five Valleys Urology', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '10065-4896', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Stephenson Cancer Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Urology', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': 'L4M 7G1 CA', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Male/Female Health and Research Centre', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'L7N 3V2', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'G Kenneth Jansz Medicine Professional Corp.', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'N2N 2B9 CA', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Urology Associates / Urologic Medical Research', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'P1B 7K8', 'city': 'North Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Urology Clinic of Dr. Goldfarb', 'geoPoint': {'lat': 46.3168, 'lon': -79.46633}}, {'zip': 'M2J 1V1', 'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Urologic Clinic of Stanley Flax'}, {'zip': '6525GA', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cepheid', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}