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OpenTrials
Completed

NCT Number: NCT05799456

Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma

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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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Free glycosaminoglycan profiling

Diagnostic Test

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.

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

Sponsors and collaborators

Lead sponsor

Jens Nielsen

Other

Collaborators

  • Göteborg University

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 5, 2023
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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