Trials / Unknown
UnknownNCT03796299
Expression of MCM5 in Urine in Patients With Urothelial Cancers
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 180 (estimated)
- Sponsor
- Medical University of Warsaw · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
In patients with non-muscle-invasive bladder cancer, the development and introduction to the clinical practice of an adequately accurate biomarker may allow to limit the indications for performing control cystoscopy. Thus, it will reduce the discomfort and stress of patients, the risk of complications of the invasive procedure and probably significantly reduce the costs incurred by healthcare systems. The aim of the present study is to determine the usefulness of the determination of MCM5 protein expression in the urine of patients with urinary bladder or upper urinary tract cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Assessment of expression of MCM5 in the urine (ADX Bladder) | Each participant will be asked to urinate in a plastic container. Urine will be centrifuged afterwards, then the expression of MCM5 protein will be examined in cells from urine sediment. For this purpose, it is planned to use the Arquer Diagnostics ADXBLADDER test. It is an enzyme linked immunosorbent assay (ELISA) using two monoclonal antibodies directed against two different epitopes. Both antibodies have high affinity and specificity for the MCM5 antigen. |
Timeline
- Start date
- 2019-01-01
- Primary completion
- 2019-08-01
- Completion
- 2019-10-01
- First posted
- 2019-01-08
- Last updated
- 2019-01-08
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT03796299. Inclusion in this directory is not an endorsement.