Measuring Urinary Nano Particles and Metallic Compounds in TCC Patients

October 13, 2022 updated by: Ilan Beniamin Klein, Carmel Medical Center

Measuring Urinary Nano Particles and Arsenic and Comparing Them to Cystoscopic Findings and Urinary Cytology in Patients Suspected With Urinary Bladder Malignancy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Carmel Lady Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with bladder cancer & control group

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
levels of nano particles and arsenic in urine
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2016

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-15-0127-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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