Evaluation Of Zetiq's Novel Cell Detect Technology For Detection Of Bladder Cancer In Urine Cytology

March 20, 2014 updated by: Zetiq Technologies

  • This study includes two semi-consecutive parts:

    • Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect® device for identifying bladder cancer cells in urine samples.
    • Part II Prospective, controlled, blinded part to determine the performance of the CellDetect® device in monitoring bladder cancer recurrence in patients with a history of TCC, using urine cytology samples
  • The following subjects will be enrolled:

Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.

Study Overview

Status

Unknown

Conditions

Detailed Description

Study aim:

  1. To calibrate the CellDetect® device for detecting TCC in urine cytology samples.
  2. Determine the performance of the CellDetect® device in identifying TCC recurrence in patients with a history of TCC using urine cytology samples.

The study includes two parts:

Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect® device for identifying bladder cancer cells in urine samples.

Part II Prospective, controlled, blinded part to determine the performance of the CellDetect® device in monitoring bladder cancer recurrence in in patients with a history of TCC, using urine cytology samples

* The following subjects will be enrolled: Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.

Part I - up to 200 urine eligible samples Part II - up to 300 urine eligible samples

Endpoints:

  1. To calibrate the CellDetect® device for identifying TCC in urine cytology samples.
  2. To determine the performance of the CellDetect® device in identifying recurrence of TCC in urine samples.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • Not yet recruiting
        • Emek Medical Center
        • Contact:
          • Michael Cohen, Dr.
          • Phone Number: +972-46494305/6
        • Principal Investigator:
          • Michael Cohen, Dr.
      • Haifa, Israel
        • Recruiting
        • Urology Department, Bnai Zion Medical Center
        • Contact:
      • Jerusalem, Israel
        • Recruiting
        • Urology Department, Hadassah Medical Center Ein Kerem
        • Contact:
      • Kfar Sava, Israel
        • Recruiting
        • Urology Department, Meir Medical Center
        • Contact:
      • Petach Tikva, Israel
        • Recruiting
        • Urology Department, Rabin Medical Center, Belinson Campus
        • Contact:
      • Tel Aviv, Israel
        • Recruiting
        • Urology Department, Sourasky Medical Center
        • Contact:
      • Tel Hashomer, Israel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The following subjects will be enrolled: Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.

Description

Part A:

*Inclusion Criteria Inclusion criteria will be different for each group subjects.

Group A (Monitoring group):

  1. Subjects diagnosed with bladder cancer undergoing routine cystoscopic surveillance, who had normal cystoscopies for at least 12 months..
  2. Ability to provide informed consent
  3. Age > 18 years

Group B (Positive group):

  1. Subject undergoing TURT or cystectomy due to any of the following reasons:

    • Subjects with suspected or known TCC (hematuria subjects)
    • Subjects with previously diagnosed TCC undergoing routine cystoscopic surveillance.
  2. Ability to provide informed consent
  3. Age > 18 years

Exclusion Criteria

  1. Participation in another clinical trial within last 30 days.
  2. Known pregnancy on day of screening.

Part B:

*Inclusion Criteria

Subjects meeting the following criteria (all of them) will be included in the study:

  1. Subject with a documented history of TCC and who are undergoing routine cystoscopic surveillance, TURBT or cystectomy
  2. At least 4 weeks have passed since any treatment for TCC (including cystoscopy and/or TURBT procedures)
  3. Ability to provide informed consent

  4. Age ≥ 18 years old

    • Exclusion Criteria

Subjects complying with any of the following exclusion criteria will be excluded from the study:

  1. Subject with catheters, neobladder or kidney stones.
  2. Subject unable to provide a spontaneous urine sample.
  3. Subject currently under any cancer drug treatment.
  4. No biopsy results available for subjects with positive findings on cystoscopy test, TURBT or cystectomy. [Note: such subjects will be excluded after recruitment and urine collection, as result of the delay in receiving biopsy results].
  5. If more than 3 months have passed between urine sample collection and TURBT or cystectomy procedures, and no second sample was taken before undergoing TURBT, subject will be excluded from the study.
  6. Subject undergoing TURBT or cystectomy whose biopsy results demonstrated abnormal findings other than TCC.
  7. Subject participated in another clinical study within the last 30 days.
  8. Known pregnancy on day of screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cystoscopic surveillance, TURT or Cystectomy
The following subjects will be enrolled: Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zetiq Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Study Registration Dates

First Submitted

March 7, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimate)

March 12, 2012

Study Record Updates

Last Update Posted (Estimate)

March 21, 2014

Last Update Submitted That Met QC Criteria

March 20, 2014

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZT-CL-04B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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