Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma

Jens Nielsen

Status: Completed

Conditions: Bladder Cancer

Treatments: Diagnostic Test: Free glycosaminoglycan profiling

Study type: Observational

Funder types: Other

Identifiers

NCT05799456

GAG-BCa-001

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria:

• Positive cytology at inclusion visit
• Intravesical instillation therapy during 6 months prior to inclusion visit

Trial design

106 participants in 2 patient groups

Bladder cancer

Treatment:

Diagnostic Test: Free glycosaminoglycan profiling

No evidence of disease

Treatment:

Diagnostic Test: Free glycosaminoglycan profiling