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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01551342

Enrollment

500

Registered

2012-03-12

Start date

2012-01-31

Completion date

Unknown

Last updated

2014-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer Transitional Cell Carcinoma

Keywords

bladder cancer, Transitional cell carcinoma (TCC)

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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 *

Countries

Israel

Outcome results