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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05982561
• Other study ID #: EIG 2023-02
• Status: Recruiting
• Start date: July 26, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Early is Good Inc.
• Contact: Thakshila Liyanage, PhD
• Phone: (317) 941-6953
• Email: thakshila[@]earlyisgood.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Recurrence
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Arkansas Urology Research Center	Little Rock	Arkansas
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Early is Good Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.