Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma

Jens Nielsen106 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

106

Conditions

Bladder Cancer

Interventions

Free glycosaminoglycan profilingDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Cases (Bladder cancer \[BCa\]) Inclusion Criteria: * Primary BCa diagnosis at cystoscopy, planned for TURB Exclusion Criteria: * No histopathological diagnosis of BCaTa-T4 N0-2 MX-0 after TURB Controls (No evidence of disease \[NED\]) Inclusion Criteria: * 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 * No history of cancer except urothelial Exclusion Criteria: * Positive cytology at inclusion visit * Intravesical instillation therapy during 6 months prior to inclusion visit

Locations (1)

Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg

Gothenburg, Sweden

Outcomes

Primary Outcomes

Area-under-the-receiving operating characteristic (ROC)-curve (AUC) for the classification of BCa versus NED

Time frame: Before primary surgery for BCa; at a post-surgical follow-up visit for controls up to 5 years from primary surgery

Data from ClinicalTrials.gov

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