Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-01-13 @ 12:58 PM
Study NCT ID:
NCT05982561
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2023-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
Sponsor:
Early is Good Inc.
Organization:
Study Overview
Official Title:
Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: