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Measuring Urinary Nano Particles and Metallic Compounds in TCC Patients

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: NCT02811952
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
Ilan Beniamin Klein, Carmel Medical Center

Brief Summary:
In many of urothelial carcinoma patients, one does not find common risk factors such as smoking. The medical center is located in an industrial city with known air and water pollution. The investigators decided to check the presence of nano particles and traces of metals in urinary samples of patients known and suspected for urothelial carcinoma and compare the results to both cystoscopic and cytological findings. The patients will fill a validated epidemiological respiratory disease survey and the results will be compared to a control group.

Condition or disease Intervention/treatment
Bladder Cancer Other: without intervention

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Measuring Urinary Nano Particles and Arsenic and Comparing Them to Cystoscopic Findings and Urinary Cytology in Patients Suspected With Urinary Bladder Malignancy
Actual Study Start Date : June 23, 2016
Actual Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
study group
Patients that need that need cystoscopy due to suspicion/known bladder malignancy.
Other: without intervention
without intervention

control group
Patients that need cystoscopy due to others reasons than malignancy.
Other: without intervention
without intervention




Primary Outcome Measures :
  1. levels of nano particles and arsenic in urine [ Time Frame: one year ]

Biospecimen Retention:   Samples Without DNA
A urine sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with bladder cancer & control group
Criteria

Inclusion Criteria:

Study group :

  1. Patients that need cystoscopy due to suspicion/known bladder malignancy.
  2. Patients that can read, understand and sign an informed consent form.

Control group:

  1. Patients that need cystoscopy due to others reasons than malignancy.
  2. Patients that present to the Department of Urology for surgery unrelated to malignancy of the urinary system ( prostatectomy, Incontinence repair, circumcision, hydrocele/ varicocele repair, ureteroscopy etc).

Exclusion Criteria:

Study group:

  1. Patients receiving bladder irrigations, pregnant women, children and those with impaired judgment
  2. Patients with a technically improper urine test.

Control group

  1. Patients receiving bladder irrigations, pregnant women, children and those with impaired judgment
  2. Patients with a technically improper urine test.

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): NCT02811952


Locations
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Israel
Carmel Lady Davis Medical Center
Haifa, Israel
Sponsors and Collaborators
Carmel Medical Center
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Responsible Party: Ilan Beniamin Klein, urologist, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT02811952    
Other Study ID Numbers: CMC-15-0127-CTIL
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ilan Beniamin Klein, Carmel Medical Center:
bladder cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases