Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer
Part of paid clinical trials in Burlington, Massachusetts.
- Sponsor
- Lahey Clinic
- Study ID
- NCT00872495
- Status
- Recruiting
Conditions
- Bladder Neoplasms
- Cancer
- Urinary Bladder Cancer
- Urothelial Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Study Details
The purpose of this study is to determine if analysis of DNA and protein material found in urine will be useful in the detection of urothelial cancer of the bladder and kidney. This analysis may be helpful to determine if how a particular cancer will act regarding remission and recurrence
Key Dates
- Start date
- Sep 30, 2002
- Status verified
- Dec 2025
- Primary completion
- Oct 31, 2028
- Completion
- Nov 30, 2028
Study Design
- Enrollment
- 500 participants (estimated)
Arms
- Arm: 1Bladder Cancer Group: Patients scheduled to have a cystectomy or cystoscopy of their bladder with possible removal or biopsy of bladder tumor or tissue. Two urine samples collected at the time of the scheduled procedure: One sample collected through voiding. The other sample collected from atheterized urine in the operating room. Additional urine samples may be collected at each follow up visit over two years. These samples will be obtained via voiding, standard urine sample collection.
- Arm: 2Control Group: Patients with no known evidence of bladder cancer. One urine sample will be collected through voiding, as with standard urine sample collection at the time of clinic visit.
Primary Outcome Measure
To evaluate the utility of emerging technologies in the detection of bladder tumor cells using non-invasive approaches utilizing voided urine samples. [ Time Frame: Ongoing Lab analysis for study duration: final data completion date ]
Central Contacts
- Kimberly Rieger-Christ, PhD781-744-2969
- Linda M. Topjian781-744-8711
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Lahey Clinic, Inc. | Burlington | Massachusetts | 01805 | Arthur Mourtzinos, M.D. (SUB_INVESTIGATOR) Andrea Sorcini, M.D. (SUB_INVESTIGATOR) Ali Moinzadeh, M.D. (SUB_INVESTIGATOR) David Canes, M.D. (SUB_INVESTIGATOR) |
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