NCT02647112

Brief Summary

Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,050

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
4 countries

6 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

Study Start

First participant enrolled

December 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

5 years

First QC Date

December 16, 2015

Last Update Submit

May 3, 2021

Conditions

Bladder Cancer

Keywords

Bladder cancerUrineMethylation

Outcome Measures

Primary Outcomes (2)

  • Sensitivity (the proportion of positives that are correctly identified as such by the gold standard)

    the proportion of positives that are correctly identified as such by the gold standard

    Day 1

  • Specificity (the proportion of negatives that are correctly identified as such by the gold standard)

    the proportion of negatives that are correctly identified as such by the gold standard

    Day 1

Study Arms (2)

Bladder EpiCheck

EXPERIMENTAL

Urine sample will be tested with the Bladder EpiCheck in conjunction with cystoscopy and cytology

Other: Bladder EpiCheck

Practice of medicine

NO INTERVENTION

Practice of medicine including cystoscopy and cytology

Interventions

Bladder EpiCheckOTHER

Urine test for the monitoring of bladder cancer recurrence

Bladder EpiCheck

Eligibility Criteria

Age22 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance monitoring for urothelial cell carcinoma
  • Has all urothelial cell carcinoma tumor resected within the past 12 months
  • Has a plan for cystoscopic surveillance

You may not qualify if:

  • Planning to undergo radical cystectomy or chemotherapy-radiation for UCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Tubingen University Medical Center

Tübingen, Germany

Location

Meir Medical Center

Kfar Saba, Israel

Location

AMC Medical Center

Amsterdam, Netherlands

Location

ZGT Medical Center

Hengelo, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Vall D'Hebron Medical Center

Barcelona, Spain

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Shmulik Adler

    Nucleix Ltd.

    STUDY DIRECTOR

  • Fred Witjes, Prof.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 16, 2015

First Posted

January 6, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

May 4, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(3)IL(1)ES(1)DE(1)