Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma

Bladder Cancer Clinical Trial

Official title:

Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05799456
• Other study ID #: GAG-BCa-001
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: February 28, 2023

Study information

• Verified date: April 2023
• Source: Chalmers University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell

Intervention

Diagnostic Test:
• Free 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.

Locations

Country	Name	City	State
Sweden	Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Jens Nielsen	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area-under-the-receiving operating characteristic (ROC)-curve (AUC) for the classification of BCa versus NED		Before primary surgery for BCa; at a post-surgical follow-up visit for controls up to 5 years from primary surgery