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

• Conditions: Bladder Cancer Transitional Cell Carcinoma

• Registration Number: NCT01551342
• Lead Sponsor: Zetiq Technologies

Brief Summary

* 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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-12
• Status Verified: 2013-08
• Last Update Submitted: 2014-03-20
• Last Update Posted: 2014-03-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (7)

Emek Medical Center; 🇮🇱 Afula, Israel

Urology Department, Hadassah Medical Center Ein Kerem; 🇮🇱 Jerusalem, Israel

Urology Department, Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Urology Department, Meir Medical Center; 🇮🇱 Kfar Sava, Israel

Urology Department, Bnai Zion Medical Center; 🇮🇱 Haifa, Israel

Urology Department, Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel

Urology Department, Rabin Medical Center, Belinson Campus; 🇮🇱 Petach Tikva, Israel