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Expression of MCM5 in Urine in Patients With Urothelial Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03796299
Recruitment Status : Unknown
Verified December 2018 by Medical University of Warsaw.
Recruitment status was:  Not yet recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

Study Description
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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.


Condition or disease Intervention/treatment
Bladder Cancer Diagnostic Test: Assessment of expression of MCM5 in the urine (ADX Bladder)

Study Design
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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Expression of MCM5 in Urine in Patients With Urothelial Cancers
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

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Groups and Cohorts
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Group/Cohort Intervention/treatment
1
Patients with bladder cancer
 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.
2
Patients with upper urinary tract cancer
 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.
3 (control)
Controls
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Expression of MCM-5 in the urine [ Time Frame: 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).


Biospecimen Retention:   Samples Without DNA
Urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients qualified for surgery due to bladder or upper urinary tract tumors and controls.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796299


Locations
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Poland
Medical University of Warsaw, Dept. of Urology
Warsaw, Poland, 02005
Sponsors and Collaborators
Medical University of Warsaw
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03796299    
Other Study ID Numbers: 4-2018
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Warsaw:
bladder cancer
biomarker
urothelial cancer
cystoscopy
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases