- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05799456
Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma
April 3, 2023 updated by: Jens Nielsen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
106
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gothenburg, Sweden
- Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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].
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Bladder cancer
|
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.
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No evidence of disease
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area-under-the-receiving operating characteristic (ROC)-curve (AUC) for the classification of BCa versus NED
Time Frame: Before primary surgery for BCa; at a post-surgical follow-up visit for controls up to 5 years from primary surgery
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Before primary surgery for BCa; at a post-surgical follow-up visit for controls up to 5 years from primary surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
February 28, 2023
Study Registration Dates
First Submitted
March 20, 2023
First Submitted That Met QC Criteria
April 3, 2023
First Posted (Actual)
April 5, 2023
Study Record Updates
Last Update Posted (Actual)
April 5, 2023
Last Update Submitted That Met QC Criteria
April 3, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GAG-BCa-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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