Measuring Urinary Nano Particles and Metallic Compounds in TCC Patients

NCT02811952 | Completed

• 1 other identifier: CMC-15-0127-CTIL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

bladder cancer

Outcome Measures

Primary Outcomes (1)

• levels of nano particles and arsenic in urine

  one year

Study Arms (2)

study group

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

Other: without intervention

control group

Patients that need cystoscopy due to others reasons than malignancy.

Other: without intervention

Interventions

without intervention OTHER

without intervention

control group; study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with bladder cancer \& control group

You may qualify if:

• Study group :
• Patients that need cystoscopy due to suspicion/known bladder malignancy.
• Patients that can read, understand and sign an informed consent form.
• Control group:
• Patients that need cystoscopy due to others reasons than malignancy.
• 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).

You may not qualify if:

• Study group:
• Patients receiving bladder irrigations, pregnant women, children and those with impaired judgment
• Patients with a technically improper urine test.
• Control group
• Patients receiving bladder irrigations, pregnant women, children and those with impaired judgment
• Patients with a technically improper urine test.

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Lady Davis Medical Center

Haifa, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A urine sample

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Methods

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: urologist

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 23, 2016
• Study Start: June 23, 2016
• Primary Completion: July 31, 2020
• Study Completion: January 1, 2021
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

IL (1)