Expression of MCM5 in Urine in Patients With Urothelial Cancers

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03796299

Enrollment

180

Registered

2019-01-08

Start date

2019-01-31

Completion date

2019-10-31

Last updated

2019-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

bladder cancer, biomarker, urothelial cancer, cystoscopy

Brief 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.

Interventions

DIAGNOSTIC_TESTAssessment 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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* age \>18 years, * written consent to participate in the study, * ability to void and collect \>50ml of urine, * recurrent bladder cancer confirmed by cystoscopy (group 1) or upper urinary tract tumor confirmed by imaging studies (group 2) or no history of urological/gynecological cancers (controls)

Exclusion criteria

* urinary tracy infection, * nephrolithiasis

Design outcomes

Primary

Measure	Time frame	Description
Expression of MCM-5 in the urine	Within 48 hours after subject enrollment	Expression of MCM-5 will be determined in urine sediment by Arquer Diagnostics ADXBLADDER test (ELISA test using two monoclonal antibodies directed against epitopes of high affinity and specificity for the MCM5 antigen).

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026