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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02538809
• Other study ID #: 2014-21
• Status: Recruiting
• Start date: August 13, 2018
• Est. completion date: February 2025

Study information

• Verified date: June 2024
• Source: Swiss Paraplegic Research, Nottwil
• Contact: Jens Wöllner
• Phone: +41 41 939 59 41
• Email: jens.woellner[@]paraplegie.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Cancer
• Spinal Cord Injuries
• Spinal Cord Injury
• Urinary Bladder Neoplasms

Intervention

Other:
• measurement of tumor mRNA concentration in urine
bed-side test of tumor mRNA concentration in urine

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urine tumor mRNA concentration		1 day
Secondary	cystoscopic findings of bladder wall	findings suspicious of bladder cancer present: yes / no	1 day
Secondary	microscopic identification of cells in bladder fluid sample		1 day
Secondary	histopathologic examination of the bladder wall biopsy	diagnosis of bladder cancer: yes / no	1 day