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

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: 1
    Bladder 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: 2
    Control 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

Locations (1)

FacilityCityStateZIPSite coordinators
Lahey Clinic, Inc.BurlingtonMassachusetts01805
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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