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

Quantitative Evaluation of a Novel MRNA-based Urine Test for Bladder Cancer in Spinal Cord Individuals with Symptoms or Clinical Findings Suspicious for Bladder Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Bladder Cancer; Spinal Cord Injury
• Intervention / Treatment: Other: measurement of tumor mRNA concentration in urine

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Switzerland
  • LU
    • Nottwil, LU, Switzerland, CH-6207
      • Swiss Paraplegic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

individuals presenting with symptoms or clinical findings suspicious for bladder cancer at a tertiary urologic referral center

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
urine tumor mRNA concentration	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Research, Nottwil
• Investigators: Principal Investigator: Jens Wöllner, Schweizer Paraplegiker-Zentrum Nottwil

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimated): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Trauma, Nervous System; Urinary Bladder Diseases; Spinal Cord Diseases; Urinary Bladder Neoplasms; Spinal Cord Injuries
• Other Study ID Numbers: 2014-21-v2

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
• product manufactured in and exported from the U.S.: No