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Sponsored by: |
Lahey Clinic |
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Information provided by: | Lahey Clinic |
ClinicalTrials.gov Identifier: | NCT00872495 |
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 bladder cancer progression. This analysis may be helpful to determine if how a particular cancer will act regarding remission and recurrence
Condition |
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Bladder Cancer Cancer Bladder Neoplasms Urinary Bladder Cancer |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Evaluation of Non-Invasive Assay(s) for the Detection of Bladder Cancer |
Urine
Estimated Enrollment: | 500 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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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. |
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Lahey Clinic patients presenting to the Department of Urology and Primary Care Referrals
Inclusion Criteria:
Exclusion Criteria:
Contact: John A. Libertino, M.D. | 781-744-2511 | John.A.Libertino@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: Ian C. Summerhayes, Ph.D. | |
Sub-Investigator: Arthur Mourtzinos, M.D. | |
Sub-Investigator: Andrea Sorcini, M.D. | |
Sub-Investigator: Karim Hamawy, M.D. | |
Sub-Investigator: Robert Roth, M.D. | |
Sub-Investigator: Leonard Zinman, M.D. | |
Sub-Investigator: Ali Moinzadeh, M.D. | |
Sub-Investigator: David Canes, M.D. |
Principal Investigator: | John A. Libertino, M.D. | Lahey Clinic, Inc. |
Responsible Party: | Lahey Clinic, Inc. ( John A. Libertino, M.D. ) |
Study ID Numbers: | 2002-061 |
Study First Received: | March 27, 2009 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00872495 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bladder Cancer Cancer Bladder Neoplasms Urinary Bladder Cancer |
Urinary Tract Neoplasm Cystocele Urologic Diseases Urinary Bladder Diseases |
Urinary Bladder Neoplasms Urogenital Neoplasms Bladder Neoplasm Urologic Neoplasms |
Neoplasms Neoplasms by Site Urologic Diseases Urinary Bladder Diseases |
Urinary Bladder Neoplasms Urogenital Neoplasms Urologic Neoplasms |