Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT05799456
Status:
COMPLETED
Last Update Posted:
2023-04-05
First Post:
2023-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-03', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area-under-the-receiving operating characteristic (ROC)-curve (AUC) for the classification of BCa versus NED', 'timeFrame': 'Before primary surgery for BCa; at a post-surgical follow-up visit for controls up to 5 years from primary surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'Early detection of bladder cancer (BCa) is considered an effective strategy to curb mortality from the disease. However, current urinary biomarkers have insufficient specificity to warrant BCa screening. Urine free glycosaminoglycan profiles (or GAGomes) are promising noninvasive biomarkers of cancer metabolism. In this study, samples are obtained from patients with BCa and controls to compare the glycosaminoglycan profiles between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospective case-control study to compare patients elected for transurethral resection of the bladder (TURB) for bladder cancer (BCa) \\[cases\\] versus patients with no evidence of disease (NED) during the follow-up of previously localised BCa \\[controls\\].', 'healthyVolunteers': False, 'eligibilityCriteria': 'Cases (Bladder cancer \\[BCa\\])\n\nInclusion Criteria:\n\n* Primary BCa diagnosis at cystoscopy, planned for TURB\n\nExclusion Criteria:\n\n* No histopathological diagnosis of BCaTa-T4 N0-2 MX-0 after TURB\n\nControls (No evidence of disease \\[NED\\])\n\nInclusion Criteria:\n\n* In follow-up with cystoscopy after treatment Ta-T3 N0-2 M0 BCa or upper tract urothelial cancer no evidence of disease at cystoscopy for at least 6 months prior to inclusion\n* No history of cancer except urothelial\n\nExclusion Criteria:\n\n* Positive cytology at inclusion visit\n* Intravesical instillation therapy during 6 months prior to inclusion visit'}, 'identificationModule': {'nctId': 'NCT05799456', 'briefTitle': 'Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Chalmers University of Technology'}, 'officialTitle': 'Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma', 'orgStudyIdInfo': {'id': 'GAG-BCa-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bladder cancer', 'interventionNames': ['Diagnostic Test: Free glycosaminoglycan profiling']}, {'label': 'No evidence of disease', 'interventionNames': ['Diagnostic Test: Free glycosaminoglycan profiling']}], 'interventions': [{'name': 'Free glycosaminoglycan profiling', 'type': 'DIAGNOSTIC_TEST', 'description': 'Free glycosaminoglycan profiling (GAGome) analysis was performed at a single blinded central laboratory using commercial kits wherein the concentration (in µg/mL) of 17 chondroitin sulfate (CS), heparan sulfate (HS), hyaluronic acid (HA) disaccharides were detected and quantified using a UHPLC-MS/MS system.', 'armGroupLabels': ['Bladder cancer', 'No evidence of disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jens Nielsen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Göteborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jens Nielsen', 'investigatorAffiliation': 'Chalmers University of Technology'}}}}