Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma

NCT ID: NCT05799456

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2023-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Bladder cancer

Free glycosaminoglycan profiling

Intervention Type 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.

No evidence of disease

Free glycosaminoglycan profiling

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Primary BCa diagnosis at cystoscopy, planned for TURB


* 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

* No histopathological diagnosis of BCaTa-T4 N0-2 MX-0 after TURB

Controls (No evidence of disease \[NED\])


* Positive cytology at inclusion visit
* Intravesical instillation therapy during 6 months prior to inclusion visit
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role collaborator

Jens Nielsen

OTHER

Sponsor Role lead

Responsible Party

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Jens Nielsen

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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GAG-BCa-001

Identifier Type: -

Identifier Source: org_study_id

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