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Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma

Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05799456
Enrollment
106
Registered
2023-04-05
Start date
2018-10-01
Completion date
2023-02-28
Last updated
2023-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Brief summary

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.

Interventions

DIAGNOSTIC_TESTFree glycosaminoglycan profiling

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.

Sponsors

Göteborg University
CollaboratorOTHER
Jens Nielsen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Area-under-the-receiving operating characteristic (ROC)-curve (AUC) for the classification of BCa versus NEDBefore primary surgery for BCa; at a post-surgical follow-up visit for controls up to 5 years from primary surgery

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026