NCT02700464

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
680

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

May 4, 2021

Status Verified

July 1, 2020

Enrollment Period

3.6 years

First QC Date

February 24, 2016

Last Update Submit

May 3, 2021

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (2)

  • Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard)

    Day 1

  • Sensitivity of Bladder EpiCheck Urine Test Kit (The proportion of positives that are correctly identified as such by the gold standard)

    Day 1

Study Arms (2)

Bladder EpiCheck Urine Test

EXPERIMENTAL

Bladder EpiCheck Urine Test

Device: Bladder EpiCheck Urine Test

Gold Standard

ACTIVE COMPARATOR

Cystoscopy and pathology

Procedure: Cystoscopy and pathology

Interventions

Bladder EpiCheck Urine TestDEVICE

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

Bladder EpiCheck Urine Test
Cystoscopy and pathologyPROCEDURE

Routine cystoscopy for bladder cancer recurrence and pathology confirmation for patients with positive cystoscopy

Gold Standard

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Chesapeake Urology Research Associates

Baltimore, Maryland, 21237, United States

Location

Michigan Institute of Urology, P.C.

Troy, Michigan, 48084, United States

Location

Metro Urology

Woodbury, Minnesota, 55125, United States

Location

Urological Surgeons of Long Island

Garden City, New York, 11530, United States

Location

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

University Of Washington

Seattle, Washington, 98195-6158, United States

Location

UHN, Princess Margret Cancer center

Toronto, Ontario, M5G 1Z5, Canada

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Shmulik Adler, MSc

    Nucleix Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 7, 2016

Study Start

September 1, 2016

Primary Completion

April 1, 2020

Study Completion

July 1, 2020

Last Updated

May 4, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(10)CA(1)