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

NCT02538809 | Terminated

• 1 other identifier: 2014-21-v2
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• urine tumor mRNA concentration

  1 day

Secondary Outcomes (3)

• cystoscopic findings of bladder wall

  1 day

• microscopic identification of cells in bladder fluid sample

  1 day

• histopathologic examination of the bladder wall biopsy

  1 day

Interventions

measurement of tumor mRNA concentration in urine OTHER

bed-side test of tumor mRNA concentration in urine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, CH-6207, Switzerland

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Spinal Cord Injuries

Interventions

Urination

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Jens Wöllner

  Schweizer Paraplegiker-Zentrum Nottwil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 2, 2015
• Study Start: August 13, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)