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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

Tracking Information
First Submitted Date June 21, 2016
First Posted Date June 23, 2016
Last Update Posted Date August 26, 2020
Actual Study Start Date June 23, 2016
Actual Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2016)		 levels of nano particles and arsenic in urine [ Time Frame: one year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measuring Urinary Nano Particles and Metallic Compounds in TCC Patients
Official Title Measuring Urinary Nano Particles and Arsenic and Comparing Them to Cystoscopic Findings and Urinary Cytology in Patients Suspected With Urinary Bladder Malignancy
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
A urine sample
Sampling Method Non-Probability Sample
Study Population patients with bladder cancer & control group
Condition Bladder Cancer
Intervention Other: without intervention
without intervention
Study Groups/Cohorts
  • study group
    Patients that need that need cystoscopy due to suspicion/known bladder malignancy.
    Intervention: Other: without intervention
  • control group
    Patients that need cystoscopy due to others reasons than malignancy.
    Intervention: Other: without intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 22, 2016)		 600
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2021
Actual Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT02811952
Other Study ID Numbers CMC-15-0127-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ilan Beniamin Klein, Carmel Medical Center
Study Sponsor Carmel Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Carmel Medical Center
Verification Date August 2020