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CompletedNCT05799456Updated Apr 5, 2023

Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma

An observational study in Bladder Cancer, sponsored by Jens Nielsen. Completed at 1 site in Sweden. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-04-05.

Sponsored by Jens Nielsen · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
106
Ages
18 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Bladder Cancer
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In context

Carcinoma, Transitional Cell

716 studies on the registry are indexed under Carcinoma, Transitional Cell; 201 are open to participants now.

This study's enrollment of 106 is below the median of 200 across 123 observational studies indexed under Carcinoma, Transitional Cell.

Browse Carcinoma, Transitional Cell studies →

Lead sponsor

Jens Nielsen is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
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].

Eligibility 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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
106 participants (actual)
Patient registry
No

Groups and cohorts

  • Bladder cancer

    Diagnostic Test: Free glycosaminoglycan profiling

  • No evidence of disease

    Diagnostic Test: Free glycosaminoglycan profiling

Interventions

  • Diagnostic testFree 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.

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What researchers measure

Primary outcomes

  1. 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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Study locations

1 site
  • Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg
    Gothenburg, Sweden
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05799456
Lead sponsor
Jens Nielsen
Collaborators
Göteborg University
Responsible party
Jens Nielsen (Professor, Chalmers University of Technology) — Sponsor-investigator
First posted
Apr 5, 2023
Start date
Oct 1, 2018
Primary completion
Feb 28, 2023
Completion
Feb 28, 2023
Last update
Apr 5, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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