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Measuring Urinary Nano Particles and Metallic Compounds in TCC Patients

I

Israel Healthcare Foundation

Status

Completed

Conditions

Bladder Cancer

Treatments

Other: without intervention

Study type

Observational

Funder types

Other

Identifiers

NCT02811952
CMC-15-0127-CTIL

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

study group
Description:
Patients that need that need cystoscopy due to suspicion/known bladder malignancy.
Treatment:
Other: without intervention
control group
Description:
Patients that need cystoscopy due to others reasons than malignancy.
Treatment:
Other: without intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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