NCT05982561

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

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 Progress93%
Jul 2023Aug 2026

Study Start

First participant enrolled

July 26, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 27, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

July 27, 2023

Last Update Submit

April 20, 2026

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Arkansas Urology Research Center

Little Rock, Arkansas, 72211, United States

RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

Washington University

St Louis, Missouri, 63130, United States

RECRUITING

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

Central Study Contacts

Thakshila Liyanage, PhD

CONTACT

(317) 941-6953thakshila@earlyisgood.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2023

First Posted

August 8, 2023

Study Start

July 26, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

US(3)