None listed
Conditions
Brief summary
Prior case-control studies on selected samples showed highly promising levels of sensitivity and specificity for uRNA. The next phase in the evaluation of the uRNA tests is to carry out a nested case-control study in a clinical population in which uRNA could potentially be useful. This would enable more accurate estimations of sensitivity and specificity as well as estimations of positive and negative predictive values for this population. This study would also enable a formal comparison of sensitivity and specificity for uRNA and each of the FDA-approved NMP22 tests. The clinical population chosen for this phase is patients with no history of TCC who present with a history of gross haematuria. This is the most common presentation for TCC and forms a relatively well defined population. In this study’s patient population, the potential use of uRNA is in conjunction with cystoscopy, where it would aim to identify TCCs which were missed during initial cystoscopy. Currently cytology is routinely used for this purpose and an alternative non-invasive assay NMP22 (Matritech) is also FDA approved for use, although it is not in routine use. The nested case control study described here will explore the value of uRNA as an adjunct to cystoscopy and in particular compare the performance of uRNA to that of cytology and the NMP22 tests for the detection of primary TCC in patients with a history of gross haematuria. Of particular interest are the relative sensitivity, specificity, positive and negative predictive values, the variation in sensitivity and specificity by grade and stage of disease, and the ability of the tests to identify invasive TCC.
Interventions
A diagnostic test (uRNA) that quantitates four messenger ribonucleic acid (mRNA) molecules in unfractionated urine. Patients provide a single urine sample prior to cystoscopy. The sample is put into a buffering solution, then the levels of mRNAs in the sample determined.
Sponsors
Pacific Edge Biotechnology Ltd
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Patients presenting with a recent history of primary gross haematuria and who require further investigation for possible urological cancer 2. No previous investigations for urinary tract cancer or TCC (with the exception of radiological imaging eg CT scan / ultrasound, or bloods) 3. Able to provide a voided urine sample 4. Able to give written informed consent 5. Able and willing to comply with study requirements 6. > 18 years
Exclusion criteria
Patients will not have any of the following: 1. Prior history of bladder malignancy, prostate or renal cell carcinoma 2. Ongoing gross haematuria less than 24 hrs prior to investigation 3. Prior genitourinary manipulation in the 14 days before urine collection 4. Current urinary tract infection 5. Current or known history of urinary tract inflammatory disorder 6. Active renal disorders which may cause haematuria eg pyelonephritis, glomerulonephritis, nephrosis, or other renal inflammatory disorders 7. Current or intermittent catheterisation within 5 days of urine sample collection 8. Recent history of pyelonephritis 9. Previous alkylating based chemotherapy 10. History of renal or pelvic trauma within last 3 months 11. Previous cystoscopy for the investigation of haematuria in the 12 months before enrolment. 12. Cystoscopy for any reason in the 6 months before enrolment.
Outcome results
None listed