The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Bladder Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2016 |
| End Date: | December 2018 |
| Contact: | Shmulik Adler, MSc |
| Email: | shmulik@nucleix.com |
| Phone: | 011-972-8-9161616 |
The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma: A Multicenter, Prospective Blinded Pivotal Study
Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder
EpiCheck test compared to the gold standard cystoscopy and pathology in patients under
monitoring for recurrence of bladder cancer.
EpiCheck test compared to the gold standard cystoscopy and pathology in patients under
monitoring for recurrence of bladder cancer.
The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA
methylation patterns in urine that are associated with bladder cancer. 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
methylation test for the detection of recurrent Urothelial Cell Carcinoma in patients with a
history of bladder cancer undergoing surveillance.
methylation patterns in urine that are associated with bladder cancer. 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
methylation test for the detection of recurrent Urothelial Cell Carcinoma in patients with a
history of bladder cancer undergoing surveillance.
Inclusion Criteria:
- Any male or female patient diagnosed with incident or recurrent Urothelial Cell
Carcinoma and undergoing surveillance at 3 month intervals.
- Has had all urothelial cell carcinoma tumor resected within the past 12 months
- Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed)
- Able to provide legally effective informed consent
- Able to produce 45mL of urine
Exclusion Criteria:
- Planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell
Carcinoma
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Moses Kelvin, MD
Phone: 615-343-2120
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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