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

This study is currently recruiting participants.
Verified March 2012 by Zetiq Technologies
Sponsor:
Information provided by (Responsible Party):
Zetiq Technologies
ClinicalTrials.gov Identifier:
NCT01551342
First received: March 7, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose
  • The study includes two parts: Open label calibration part and prospective blinded part to determine the feasibility of CellDetect® device to identify bladder cancer in urine cytology samples.

  • The following subjects will be enrolled:

    • Subjects diagnosed with bladder cancer undergoing routine cystoscopic surveillance
    • Subjects undergoing TURTor Cystectomy procedures

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:

U.S. FDA Resources

Further study details as provided by Zetiq Technologies:

Biospecimen Retention:   Samples With DNA

urine samples


Estimated Enrollment: 300
Study Start Date: January 2012
Groups/Cohorts
routine cystoscopic surveillance
Subjects diagnosed with bladder cancer undergoing routine cystoscopic surveillance
TURT or Cystectomy procedures
Subjects undergoing TURT or Cystectomy procedures

Detailed Description:

Study aim:

  1. Calibrate the CellDetect® device for detecting bladder cancer (TCC) in urine cytology samples.
  2. Determine the feasibility of CellDetect® device to detect bladder cancer in urine cytology samples.

The study includes two parts: Open label calibration part and prospective blinded part to determine the feasibility of CellDetect® device to identify bladder cancer in urine cytology samples.

* The following subjects will be enrolled:

  • Subjects diagnosed with bladder cancer undergoing routine cystoscopic surveillance
  • Subjects undergoing TURTor Cystectomy procedures

Part I - up to 100 urine eligible samples Part II - up to 200 urine eligible samples

Endpoints:

  1. Calibrate the CellDetect® device for identifying TCC in urine cytology.
  2. Show reproducibility and performance of the calibrated product in urine cytology samples.
  3. Provide preliminary data showing the feasibility of CellDetect® device to correctly identify 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 diagnosed with bladder cancer undergoing routine cystoscopic surveillance.

Subjects undergoing TURTor Cystectomy procedures

Criteria

Inclusion Criteria:

Inclusion criteria will be different for each group subjects.

Group A:

  1. Subjects diagnosed with bladder cancer and have no history of disease recurrence for over 12 month from last treatment and are undergoing routine cystoscopic surveillance.
  2. Ability to provide informed consent
  3. Age > 18 years

Group B:

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

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

Exclusion Criteria:

  1. Subject currently under other cancer drug treatment or subject completed cancer drug treatment less than 4 weeks prior to study screening.
  2. Participation in another clinical trial within last 30 days.
  3. Known pregnancy on day of screening.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551342

Locations
Israel
Rabin Medical Center, Belinson Campus Recruiting
Petach Tikva, Israel
Contact: Ofer Yossepowitch, Dr     972-3-9376553     oferu@clalit.org.il    
Sheba Medical Center Not yet 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 7, 2012
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 May 22, 2013