Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma
1 other identifier
observational
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedFirst Submitted
Initial submission to the registry
March 20, 2023
CompletedFirst Posted
Study publicly available on registry
April 5, 2023
CompletedApril 5, 2023
April 1, 2023
4.4 years
March 20, 2023
April 3, 2023
Conditions
Outcome Measures
Primary Outcomes (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
Study Arms (2)
Bladder cancer
No evidence of disease
Interventions
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 Criteria
Prospective case-control study to compare patients elected for transurethral resection of the bladder (TURB) for bladder cancer (BCa) \[cases\] versus patients with no evidence of disease (NED) during the follow-up of previously localised BCa \[controls\].
You may qualify if:
- Primary BCa diagnosis at cystoscopy, planned for TURB
You may not qualify if:
- No histopathological diagnosis of BCaTa-T4 N0-2 MX-0 after TURB
- Controls (No evidence of disease \[NED\])
- No history of cancer except urothelial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jens Nielsenlead
- Göteborg Universitycollaborator
Study Sites (1)
Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg
Gothenburg, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 20, 2023
First Posted
April 5, 2023
Study Start
October 1, 2018
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
April 5, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share