Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer
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|ClinicalTrials.gov Identifier: NCT00872495|
Recruitment Status : Recruiting
First Posted : March 31, 2009
Last Update Posted : August 6, 2021
|Condition or disease|
|Urothelial Cancer Cancer Bladder Neoplasms Urinary Bladder Cancer|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer of the Bladder and Kidney|
|Study Start Date :||September 2002|
|Estimated Primary Completion Date :||October 2025|
|Estimated Study Completion Date :||November 2025|
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.
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.
- 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 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872495
|Contact: Kimberly Rieger-Christ, PhD||781-744-2969||Kimberly.R.Christ@lahey.org|
|Contact: Linda M. Topjian||781-744-8711||Linda.M.Topjian@Lahey.org|
|United States, Massachusetts|
|Lahey Clinic, Inc.||Recruiting|
|Burlington, Massachusetts, United States, 01805|
|Sub-Investigator: Arthur Mourtzinos, M.D.|
|Sub-Investigator: Andrea Sorcini, M.D.|
|Sub-Investigator: Ali Moinzadeh, M.D.|
|Sub-Investigator: David Canes, M.D.|
|Principal Investigator:||Kimberly Rieger-Christ, PhD||Lahey Clinic, Inc.|