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RecruitingNCT05982561Updated Apr 23, 2026

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

An observational study in Bladder Cancer, sponsored by Early is Good Inc.. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Early is Good Inc. · Observational

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Bladder Cancer
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In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 500 is above the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

This is the only study on the registry with Early is Good Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
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What researchers measure

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)

    Time frame: Participants' urine samples will be collected before cystoscopy and analyzed using the BCDx test within 6 months to establish its overall performance characteristics.

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Study locations

3 of 3 sites recruiting
  • Arkansas Urology Research Center
    Little Rock, Arkansas 72211, United States
    • Marotte, · Contact
    • Jeff Marotte, MD · Principal investigator
    Recruiting
  • Indiana University School of Medicine
    Indianapolis, Indiana 46202, United States
    • Hristos Kaimakliotis, MD · Principal investigator
    Recruiting
  • Washington University
    St Louis, Missouri 63130, United States
    • Eric Kim, MD · Principal investigator
    • Zeynep G. Gul, MD · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05982561
Lead sponsor
Early is Good Inc.
Responsible party
Sponsor
First posted
Aug 8, 2023
Start date
Jul 26, 2023
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Apr 23, 2026

Study contacts

Thakshila Liyanage, PhD
Contact
thakshila@earlyisgood.com
(317) 941-6953
View the source record on ClinicalTrials.gov ↗

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