- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02538809
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jens Wöllner
- Phone Number: +41 41 939 59 41
- Email: jens.woellner@paraplegie.ch
Study Locations
-
-
LU
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Nottwil, LU, Switzerland, CH-6207
- Recruiting
- Swiss Paraplegic Centre
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cystoscopic findings of bladder wall
Time Frame: 1 day
|
findings suspicious of bladder cancer present: yes / no
|
1 day
|
microscopic identification of cells in bladder fluid sample
Time Frame: 1 day
|
1 day
|
|
histopathologic examination of the bladder wall biopsy
Time Frame: 1 day
|
diagnosis of bladder cancer: yes / no
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jens Wöllner, Schweizer Paraplegiker-Zentrum Nottwil
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-21 (Ethic committee of China-Japan Friendship Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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