Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-25 @ 2:19 PM
Study NCT ID:
NCT00318266
Status:
COMPLETED
Last Update Posted:
2017-08-25
First Post:
2006-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers.
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': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-24', 'studyFirstSubmitDate': '2006-04-24', 'studyFirstSubmitQcDate': '2006-04-24', 'lastUpdatePostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Detection of Bladder Cancer using NMP22 Urine Test Kit'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'It is hypothesized that the NMP22(Nuclear Matrix Protein) Bladder Check ® Test will demonstrate improved sensitivity over that of standard urine cytology for patients with superficial transitional cell carcinoma at high risk of recurrence.', 'detailedDescription': 'Patients who have been previously treated for bladder cancer and are at a high risk for recurrence are being monitored for recurrence every 3 months with urine cytology and cystoscopy as part of standard care.The NMP22 Bladder Cancer ® Test Kit has been designed to provide an alternative to regular urine cytology. A urine sample will be provided and divided with a portion being used to assess the NMP22 test kit and the remaining sample to be sent to the lab for regular urine cytology. Patient charts will be reviewed by a medical student to record age, clinical stage, pathologic stage, time to disease progression/recurrence, site of recurrence and survival data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with a history og pTis, pT1, larger ( \\>2 cm) pTa or multiple pTa bladder tumors.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* · History of pTis, pT1, large (\\>2cm) pTa or multiple pTa bladder cancer tumours.\n\nWritten Informed Consent prior to any study-related procedures.\n\nExclusion Criteria:\n\n* History of bladder cancer tumours other than those listed in inclusion'}, 'identificationModule': {'nctId': 'NCT00318266', 'briefTitle': 'NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers.', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'NMP22 Provides Improved Sensitivity in Detecting Bladder Cancers', 'orgStudyIdInfo': {'id': 'R-05-885'}, 'secondaryIdInfos': [{'id': '11720E'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with suerficial transitional cell carcinoma', 'interventionNames': ['Device: Nuclear Matrix Protein 22 Urine sample kit']}], 'interventions': [{'name': 'Nuclear Matrix Protein 22 Urine sample kit', 'type': 'DEVICE', 'description': 'Urine sample obtained from patient will be tested with the NMP22 sample kit to see if it can detect bladder cancer.', 'armGroupLabels': ['patients with suerficial transitional cell carcinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4G5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Jonathan Izawa, MD FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}