Bladder CancerNCT02538809
Novel mRNA-based Urine Test for Bladder Cancer in Spinal Cord Injury Individuals
An observational study of Bladder Cancer and Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Spinal Cord Injury
- What is being tested?
- measurement of tumor mRNA concentration in urine
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Aug 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: individuals presenting with symptoms or clinical findings suspicious for bladder cancer at a tertiary urologic referral center
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, CH-6207
About this study
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
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.
Read more
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
- Being tested
- measurement of tumor mRNA concentration in urine
- Medical subject headings
- Urinary Bladder Neoplasms, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of tumor mRNA concentration in urineOther
bed-side test of tumor mRNA concentration in urine
What is being measured
The primary outcome is the main question the study is designed to answer.
urine tumor mRNA concentration
Measured: 1 day
Secondary outcomes (3)
cystoscopic findings of bladder wall
findings suspicious of bladder cancer present: yes / no
Measured: 1 day
microscopic identification of cells in bladder fluid sample
Measured: 1 day
histopathologic examination of the bladder wall biopsy
diagnosis of bladder cancer: yes / no
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study start13 Aug 2018
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jens Wöllner, Principal investigator, Schweizer Paraplegiker-Zentrum Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538809
- Sponsor's protocol ID
- 2014-21-v2
- Status last verified
- Feb 2025
- First submitted
- 27 Aug 2015
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02538809
- Acronym / sponsor ID
- 2014-21-v2
- Conditions
- Bladder Cancer, Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- individuals presenting with symptoms or clinical findings suspicious for bladder cancer at a tertiary urologic referral center
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Age < 18 years
- History of bleeding disorder
- Bladder augmentation
- Acute, symptomatic urinary tract infection
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of tumor mRNA concentration in urinebed-side test of tumor mRNA concentration in urine | Other | – |
Primary outcome
urine tumor mRNA concentration
Time frame: 1 day
3 secondary outcomes
cystoscopic findings of bladder wall
Time frame: 1 day
microscopic identification of cells in bladder fluid sample
Time frame: 1 day
histopathologic examination of the bladder wall biopsy
Time frame: 1 day
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Wöllner principal investigator
Schweizer Paraplegiker-Zentrum Nottwil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urine tumor mRNA concentration (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.