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Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00872495
Recruitment Status : Recruiting
First Posted : March 31, 2009
Last Update Posted : August 6, 2021
Information provided by (Responsible Party):
Linda Topjian, Lahey Clinic

Brief Summary:
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

Condition or disease
Urothelial Cancer Cancer Bladder Neoplasms Urinary Bladder Cancer

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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.

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Lahey Clinic patients presenting to the Department of Urology and Primary Care Referrals

Inclusion Criteria:

  • Patients scheduled to have a nephroureterectomy, cystectomy, cytoscopy (newly diagnosed bladder cancer and those with recurrent disease in follow up)
  • Control Group: No known evidence of bladder cancer-one urine sample
  • > than 18 years of age

Exclusion Criteria:

  • < than 18 years of age

Information from the National Library of Medicine

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 identifier (NCT number): NCT00872495

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Contact: Kimberly Rieger-Christ, PhD 781-744-2969
Contact: Linda M. Topjian 781-744-8711

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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.         
Sponsors and Collaborators
Lahey Clinic
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Principal Investigator: Kimberly Rieger-Christ, PhD Lahey Clinic, Inc.
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Responsible Party: Linda Topjian, study coordinator, Lahey Clinic Identifier: NCT00872495    
Other Study ID Numbers: 2002-061
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: August 2021
Keywords provided by Linda Topjian, Lahey Clinic:
Urothelial Cancer
Bladder Neoplasms
Urinary Bladder Cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases