Measuring Urinary Nano Particles and Metallic Compounds in TCC Patients

Completed

• Conditions: Bladder Cancer
• Interventions: Other: without intervention

• Registration Number: NCT02811952
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-22
• Study Start: 2016-06-23
• Study First Posted: 2016-06-23
• Primary Completion: 2020-07-31
• Study Completion: 2021-01-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
levels of nano particles and arsenic in urine	one year

Trial Locations

Locations (1)

Carmel Lady Davis Medical Center; 🇮🇱 Haifa, Israel