Novel MRNA-based Urine Test for Bladder Cancer in Spinal Cord Injury Individuals

Terminated

• Conditions: Bladder Cancer; Spinal Cord Injury

• Registration Number: NCT02538809
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

Brief Summary

Bladder cancer is a well-recognized complication in spinal cord injury (SCI) individuals. The observed incidence rates in SCI individuals are considerably higher compared to the general population. Bladder cancer in SCI individuals tends to present at an earlier age compared to the general population. Furthermore, bladder cancer in SCI individuals is more commonly invasive and at a more advanced stage at the time of diagnosis compared to bladder cancer in the general population. Individuals with bladder cancer commonly present with hematuria and other urinary symptoms. The gold standard for diagnosis is cystoscopy. However in SCI individuals, hematuria may get attributed to catheter irritation or trauma or an urinary tract infection. Furthermore, the bladder wall commonly presents with various changes under cystoscopic examination masking the presence of a bladder wall mass. Thus, diagnosis of bladder cancer in SCI individuals can be complicate.

There is a novel test available (GeneXpert® Bladder Cancer Detection, Cepheid International, Sunnyvale, CA, USA) for the measurement of mRNA bladder tumor markers in the urine. The diagnostic accuracy of this test has been investigated in non-SCI individuals with symptoms suspicious for bladder cancer. The test showed high sensitivity and specificity values and is thus a promising diagnostic or screening tool.. However, the diagnostic accuracy of the test has not yet been investigated in SCI individuals.

The primary objective of the proposed study is to investigate whether urine mRNA tumor marker levels in spinal cord injury individuals with symptoms and findings suspicious for bladder cancer are a discriminator between individuals suffering from bladder cancer and those not suffering from cancer.

Individuals presenting with symptoms suspicious of bladder cancer will undergo ultrasonic and cystoscopic examination of the bladder. An urine sample will be taken, and the bladder will be flushed for collecting a bladder fluid sample. In patients with bladder wall findings suspicious of cancer, a bladder wall biopsy will be taken, according to clinical standard practice. The bladder fluid and the bladder wall biopsy will be submitted for cytology and histopathology examination, respectively. Tumor mRNA levels will be measured in the urine sample.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-02
• Study Start: 2018-08-13
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Symptoms suspicious of bladder cancer (haematuria, ultrasonic and cystoscopy findings)
• Chronic spinal cord injury for a minimum of 3 years
• Informed Consent as documented by signature

Exclusion Criteria

• Age < 18 years
• History of bleeding disorder
• Bladder augmentation
• Acute, symptomatic urinary tract infection
• Pregnancy
• Urolithiasis
• Previous intravesical treatment (e.g. bladder irrigation, botulinum toxin injection) < 2 weeks)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
urine tumor mRNA concentration	1 day

Secondary Outcome Measures

Name	Time	Method
cystoscopic findings of bladder wall	1 day	findings suspicious of bladder cancer present: yes / no
histopathologic examination of the bladder wall biopsy	1 day	diagnosis of bladder cancer: yes / no
microscopic identification of cells in bladder fluid sample	1 day

Trial Locations

Locations (1)

Swiss Paraplegic Centre; 🇨🇭 Nottwil, LU, Switzerland