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BRIEF TITLE: The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study

The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study


  • Org Study ID: UC-EpiCheck-FDA-01
  • Secondary ID:
  • NCT ID: NCT02700464
  • NCT Alias:
  • Sponsor: Nucleix Ltd. - Industry
  • Source: Nucleix Ltd.

Brief Summary

Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of bladder cancer.

Detailed Description


The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA
methylation patterns in urine that are associated with bladder cancer. It is intended for use
as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy
inpatients previously diagnosed with bladder cancer This is a, multicenter, prospective,
blinded study to evaluate the efficacy (sensitivity and specificity) of a novel methylation
test for the detection of recurrent Urothelial Cell Carcinoma in patients with a history of
bladder cancer undergoing surveillance.

Overal Status Start Date Phase Study Type
Recruiting September 2016 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard)

Primary Outcome 1 - Time Frame: Day 1

Primary Outcome 2 - Measure: Sensitivity of Bladder EpiCheck Urine Test Kit (The proportion of positives that are correctly identified as such by the gold standard)

Primary Outcome 2 - Time Frame: Day 1

Condition:

  • Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Any male or female patient diagnosed with incident or recurrent Urothelial Cell
Carcinoma and undergoing surveillance at 3 month intervals.

- Has had all urothelial cell carcinoma tumor resected within the past 12 months

- Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed)

- Able to provide legally effective informed consent

- Able to produce 45mL of urine

Exclusion Criteria:

- Planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell
Carcinoma
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Gender: All

Minimum Age: 22 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Shmulik Adler, MSc

Role: Study Director

Affiliation: Nucleix Ltd.

Overall Contact

Name: Shmulik Adler, MSc

Phone: 011-972-8-9161616

Email: shmulik@nucleix.com

Locations

Facility Status Contact
Chesapeake Urology Research Associates
Baltimore, Maryland 21237
United States
Recruiting Renee Hammond
443-471-5749
rhammond@cua.md
Metro Urology
Woodbury, Minnesota 55125
United States
Not yet recruiting Diane Kachel
612-819-0533
DKachel@mnurology.com
Urological Surgeons of Long Island
Garden City, New York 11530
United States
Recruiting Diane Gerrity
516-742-3200
dgerrity@prohealthcare.com
Duke University Health System
Durham, North Carolina 27710
United States
Recruiting Denise Lech
919-681-7348
denise.lech@duke.edu
Cleveland Clinic
Cleveland, Ohio 44195
United States
Recruiting Joanna Homann
216-444-0124
HOMANNJ@ccf.org
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Recruiting Pam Steele, RN
615-343-2120
pamela.steele@Vanderbilt.Edu
Urology San Antonio
San Antonio, Texas 78229
United States
Recruiting Jennifer Cruz
210-617-4116
Jennifer.Cruz@urologysa.com
University Of Washington
Seattle, Washington 98195-6158
United States
Recruiting Alexandria Lahdya
949-294-9084
azlahdya@uw.edu
UHN, Princess Margret Cancer center
Toronto, Ontario M5G 1Z5
Canada
Recruiting Parisa Sairafi
416-946-4501
Parisa.Sairafi@uhn.ca