Clinical Evaluation of BCDx for Monitoring of Recurrence... | NCT05982561

Studies
Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer

NCT05982561

Sponsor

Early is Good Inc.

Status

Recruiting

Last Update Posted

Apr 23, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Bladder Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 26, 2023Actual

Primary Completion Date

Aug 31, 2026Estimated

Completion Date

Aug 31, 2026Estimated

First Submitted Date

Jul 27, 2023

First Submission Date that Met QC Criteria

Aug 6, 2023

First Posted Date

Aug 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2026

Last Update Posted Date

Apr 23, 2026Actual

Description Module

Brief Summary

BCDx is a urine-based multi-omic assay for early cancer recurrence detection in patients with a history of bladder cancer. This prospective, blinded study evaluates its efficacy in detecting recurrent NMIBC, offering a noninvasive monitoring solution.

Detailed Description

BCDx is a urine-based multi-omic/multiplex molecular assay offers a promising solution for detecting cancer recurrence. 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 multi-omics test for the detection of recurrent NMIBC in patients with a history of bladder cancer undergoing surveillance.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of BCDx (the proportion of negatives that are correctly identified as such by the gold standard)		Participants' urine samples will be collected before cystoscopy and analyzed using the BCDx test within 6 months to establish its overall performance characteristics.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 Years and older
Patients who have been diagnosed with incident or recurrent NMIBC within the past 2 years and undergoing standard of care/routine monitoring cystoscopy.
Patients who are able to provide legally effective informed consent.
Patients who are able to provide minimum 30mL of voided urine.

Exclusion Criteria:

Patients planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing cystoscopic surveillance for non-muscle invasive bladder cancer (NMIBC) follow-up.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thakshila Liyanage, PhD	Contact	(317) 941-6953		thakshila@earlyisgood.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Urology Research Center	Recruiting	Little Rock	Arkansas	72211	United States

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided