Expression of MCM5 in Urine in Patients With Urothelial Cancers

Medical University of Warsaw

Status: Unknown

Conditions: Bladder Cancer

Treatments: Diagnostic Test: Assessment of expression of MCM5 in the urine (ADX Bladder)

Study type: Observational

Funder types: Other

Identifiers

NCT03796299

4-2018

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

180 participants in 3 patient groups

1

Description:

Patients with bladder cancer

Treatment:

Diagnostic Test: Assessment of expression of MCM5 in the urine (ADX Bladder)

2

Description:

Patients with upper urinary tract cancer

Treatment:

Diagnostic Test: Assessment of expression of MCM5 in the urine (ADX Bladder)

3 (control)

Description:

Controls

Treatment:

Diagnostic Test: Assessment of expression of MCM5 in the urine (ADX Bladder)