Measuring Urinary Nano Particles and Metallic Compounds in TCC Patients

• Sponsor: Carmel Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02811952
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Anticipated Duration (Months): 60.3
• Patients Per Site Per Month: 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Other: without intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 600 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Measuring Urinary Nano Particles and Arsenic and Comparing Them to Cystoscopic Findings and Urinary Cytology in Patients Suspected With Urinary Bladder Malignancy
• Actual Study Start Date: Jun 23, 2016
• Actual Primary Completion Date: Jul 31, 2020
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. levels of nano particles and arsenic in urine [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carmel Lady Davis Medical Center	Haifa		Israel

Sponsors and Collaborators

• Carmel Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ilan Beniamin Klein, urologist, Carmel Medical Center
• ClinicalTrials.gov Identifier: NCT02811952
• Other Study ID Numbers: CMC-15-0127-CTIL
• First Posted: Jun 23, 2016
• Last Update Posted: Aug 26, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Ilan Beniamin Klein, urologist, Carmel Medical Center: bladder cancer
• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

No Results Posted as of Aug 26, 2020