Expression of MCM5 in Urine in Patients With Urothelial Cancers

NCT03796299 | Unknown

• 1 other identifier: 4-2018
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

bladder cancer; biomarker; urothelial cancer; cystoscopy

Outcome Measures

Primary Outcomes (1)

• Expression of MCM-5 in the urine

  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).

  Within 48 hours after subject enrollment

Study Arms (3)

1

Patients with bladder cancer

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

2

Patients with upper urinary tract cancer

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

3 (control)

Controls

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

Interventions

Assessment of expression of MCM5 in the urine (ADX Bladder) DIAGNOSTIC_TEST

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.

1; 2; 3 (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients qualified for surgery due to bladder or upper urinary tract tumors and controls.

You may qualify if:

• 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)

You may not qualify if:

• urinary tracy infection,
• nephrolithiasis

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw, Dept. of Urology

Warsaw, 02005, Poland

Location

Related Publications (1)

• Bialek L, Czerwinska K, Fus L, Krajewski W, Sadowska A, Radziszewski P, Dobruch J, Kryst P, Poletajew S. MCM5 urine expression (ADXBLADDER) is a reliable biomarker of high-risk non- muscle-invasive bladder cancer recurrence: A prospective matched case-control study. Cancer Biomark. 2021;30(2):139-143. doi: 10.3233/CBM-200316.

  PMID: 32924986 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 8, 2019
• Study Start: January 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 8, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)