To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
NCT ID:
NCT05982561
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Recurrence
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients undergoing cystoscopic surveillance for non-muscle invasive bladder cancer
(NMIBC) follow-up.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arkansas Urology Research Center
Address:
City:
Little Rock
Zip:
72211
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marotte,
Investigator:
Last name:
Jeff Marotte, MD
Email:
Principal Investigator
Facility:
Name:
Indiana University School of Medicine
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Hristos Kaimakliotis, MD
Email:
Principal Investigator
Facility:
Name:
Washington University
Address:
City:
Saint Louis
Zip:
63130
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Eric Kim, MD
Email:
Principal Investigator
Investigator:
Last name:
Zeynep G. Gul, MD
Email:
Principal Investigator
Start date:
July 26, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Early is Good Inc.
Agency class:
Industry
Source:
Early is Good Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05982561
