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

NCT01551342 | Unknown

• 1 other identifier: ZT-CL-04B
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 7

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.

Conditions

Bladder Cancer Transitional Cell Carcinoma

Keywords

bladder cancer; Transitional cell carcinoma (TCC)

Study Arms (1)

Cystoscopic surveillance, TURT or Cystectomy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Group A (Monitoring group):
• Subjects diagnosed with bladder cancer undergoing routine cystoscopic surveillance, who had normal cystoscopies for at least 12 months..
• Ability to provide informed consent
• Age \> 18 years
• Group B (Positive group):
• 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.
• Ability to provide informed consent
• Age \> 18 years

You may not qualify if:

• Participation in another clinical trial within last 30 days.
• Known pregnancy on day of screening.
• Part B:
• Subjects meeting the following criteria (all of them) will be included in the study:
• Subject with a documented history of TCC and who are undergoing routine cystoscopic surveillance, TURBT or cystectomy
• At least 4 weeks have passed since any treatment for TCC (including cystoscopy and/or TURBT procedures)
• Ability to provide informed consent
• Age ≥ 18 years old
• Subject with catheters, neobladder or kidney stones.
• Subject unable to provide a spontaneous urine sample.
• Subject currently under any cancer drug treatment.
• No biopsy results available for subjects with positive findings on cystoscopy test, TURBT or cystectomy. \[Note: such subjects will be excluded after recruitment and urine collection, as result of the delay in receiving biopsy results\].
• 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.
• Subject undergoing TURBT or cystectomy whose biopsy results demonstrated abnormal findings other than TCC.
• Subject participated in another clinical study within the last 30 days.

Sponsors & Collaborators

• Zetiq Technologies: lead

Study Sites (7)

Emek Medical Center

Afula, Israel

NOT YET RECRUITING

Urology Department, Bnai Zion Medical Center

Haifa, Israel

RECRUITING

Urology Department, Hadassah Medical Center Ein Kerem

Jerusalem, Israel

RECRUITING

Urology Department, Meir Medical Center

Kfar Saba, Israel

RECRUITING

Urology Department, Rabin Medical Center, Belinson Campus

Petah Tikva, Israel

RECRUITING

Urology Department, Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Urology Department, Sheba Medical Center

Tel Litwinsky, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

urine samples

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 12, 2012
• Study Start: January 1, 2012
• Last Updated: March 21, 2014

Record last verified: 2013-08

Locations

IL (7)