MedTrace Logo

The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma

NCT02700464 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2021-05-04

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Bladder EpiCheck Urine Test

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

PROCEDURE

Cystoscopy and pathology

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

Sponsors & Collaborators

  • Nucleix Ltd.

    lead INDUSTRY

Principal Investigators

  • Shmulik Adler, MSc · Nucleix Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2020-04-30
Completion
2020-07-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02700464 on ClinicalTrials.gov