Measuring Urinary Nano Particles and Metallic Compounds in TCC Patients

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811952
• Other study ID #: CMC-15-0127-CTIL
• Status: Completed
• Start date: June 23, 2016
• Est. completion date: January 1, 2021

Study information

• Verified date: October 2022
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2021
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• without intervention
without intervention

Locations

Country	Name	City	State
Israel	Carmel Lady Davis Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	levels of nano particles and arsenic in urine		one year