Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma

• Sponsor: Jens Nielsen (Other)
• Overall Status: Completed
• CT.gov ID: NCT05799456
• Collaborator: Göteborg University (Other)
• Enrollment: 106
• Location: 1
• Actual Duration (Months): 52.9
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Diagnostic Test: Free glycosaminoglycan profiling

Study Design

• Study Type: Observational
• Actual Enrollment: 106 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma
• Actual Study Start Date: Oct 1, 2018
• Actual Primary Completion Date: Feb 28, 2023
• Actual Study Completion Date: Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Bladder cancer	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.
No evidence of disease	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.

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg	Gothenburg		Sweden

Sponsors and Collaborators

• Jens Nielsen
• Göteborg University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jens Nielsen, Professor, Chalmers University of Technology
• ClinicalTrials.gov Identifier: NCT05799456
• Other Study ID Numbers: GAG-BCa-001
• First Posted: Apr 5, 2023
• Last Update Posted: Apr 5, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma, Transitional Cell

Study Results

No Results Posted as of Apr 5, 2023