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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Zetiq Technologies
Sponsor:
Information provided by (Responsible Party):
Zetiq Technologies
ClinicalTrials.gov Identifier:
NCT01551342
First received: March 7, 2012
Last updated: March 20, 2014
Last verified: August 2013
  Purpose
  • 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.


Condition
Bladder Cancer Transitional Cell Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation Of Zetiq's Novel Cell Detect Technology For Detection Of Bladder Cancer In Urine Cytology

Resource links provided by NLM:


Further study details as provided by Zetiq Technologies:

Biospecimen Retention:   Samples With DNA

urine samples


Estimated Enrollment: 500
Study Start Date: January 2012
Groups/Cohorts
Cystoscopic surveillance, TURT or Cystectomy
The following subjects will be enrolled: Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551342

Locations
Israel
Emek Medical Center Not yet recruiting
Afula, Israel
Contact: Michael Cohen, Dr.    +972-46494305/6      
Principal Investigator: Michael Cohen, Dr.         
Urology Department, Bnai Zion Medical Center Recruiting
Haifa, Israel
Contact: Ofer Nativ, Prof.    972-4-8359523    ofer.nativ@b-zion.org.il   
Urology Department, Hadassah Medical Center Ein Kerem Recruiting
Jerusalem, Israel
Contact: Ofer Gofrit, Prof.    972-2-6510785    ogofrit@gmail.com   
Urology Department, Meir Medical Center Recruiting
Kfar Sava, Israel
Contact: Ilan Leibovitch, Prof.    972-9-7471557    leibovitchi@clalit.org.il   
Urology Department, Rabin Medical Center, Belinson Campus Recruiting
Petach Tikva, Israel
Contact: Ofer Yossepowitch, Dr    972-3-9376553    oferu@clalit.org.il   
Urology Department, Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Haim Matzkin, Prof.    972-3-6973265    hmatzkin@tamc.health.gov.il   
Urology Department, Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: Yoram Mor, Prof.    972-35302413    yoram.mor@sheba.health.gov.il   
Sponsors and Collaborators
Zetiq Technologies
  More Information

No publications provided

Responsible Party: Zetiq Technologies
ClinicalTrials.gov Identifier: NCT01551342     History of Changes
Other Study ID Numbers: ZT-CL-04B
Study First Received: March 7, 2012
Last Updated: March 20, 2014
Health Authority: Israel: Ethics Commission

Keywords provided by Zetiq Technologies:
bladder cancer
Transitional cell carcinoma (TCC)

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 26, 2014