Novel mRNA-based Urine Test for Bladder Cancer in Spinal Cord Injury Individuals
Rekrutierend
NCT-Nummer:
NCT02538809
Studienbeginn:
August 2018
Letztes Update:
09.03.2023
Wirkstoff:
-
Indikation (Clinical Trials):
Urinary Bladder Neoplasms, Spinal Cord Injuries
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Swiss Paraplegic Research, Nottwil
Collaborator:
-
Studienleiter
Jens Wöllner
Principal Investigator
Schweizer Paraplegiker-Zentrum Nottwil
Kontakt
Jens Wöllner
Kontakt:
Phone: +41 41 939 59 41
E-Mail: jens.woellner@paraplegie.ch» Kontaktdaten anzeigen
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.
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)
Primary outcome:
1. urine tumor mRNA concentration (Time Frame - 1 day)
Secondary outcome:
1. cystoscopic findings of bladder wall (Time Frame - 1 day):
findings suspicious of bladder cancer present: yes / no
2. microscopic identification of cells in bladder fluid sample (Time Frame - 1 day)
3. histopathologic examination of the bladder wall biopsy (Time Frame - 1 day):
diagnosis of bladder cancer: yes / no
- measurement of tumor mRNA concentration in urine:
bed-side test of tumor mRNA concentration in urine
Quelle: ClinicalTrials.gov
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