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

  • Sweden
      • Gothenburg, Sweden
        • Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg

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
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.

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
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

Jens Nielsen

Collaborators

Göteborg University

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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