Measuring Urinary Nano Particles and Metallic Compounds in TCC Patients

NCT ID: NCT02811952

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-23

Study Completion Date

2021-01-01

Brief Summary

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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

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Conditions

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Bladder Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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study group

Patients that need that need cystoscopy due to suspicion/known bladder malignancy.

without intervention

Intervention Type OTHER

without intervention

control group

Patients that need cystoscopy due to others reasons than malignancy.

without intervention

Intervention Type OTHER

without intervention

Interventions

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without intervention

without intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ilan Beniamin Klein

urologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Carmel Lady Davis Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CMC-15-0127-CTIL

Identifier Type: -

Identifier Source: org_study_id

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