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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Lahey Clinic
Sponsor:
Information provided by (Responsible Party):
Linda Topjian, Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00872495
First received: March 27, 2009
Last updated: December 18, 2015
Last verified: December 2015
  Purpose
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
Urothelial Cancer
Cancer
Bladder Neoplasms
Urinary Bladder Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Urine

Estimated Enrollment: 500
Study Start Date: September 2002
Estimated Study Completion Date: November 2025
Estimated Primary Completion Date: October 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Lahey Clinic patients presenting to the Department of Urology and Primary Care Referrals
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872495

Contacts
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

Locations
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: Leonard Zinman, M.D.         
Sub-Investigator: Ali Moinzadeh, M.D.         
Sub-Investigator: David Canes, M.D.         
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Kimberly Rieger-Christ, PhD Lahey Clinic, Inc.
  More Information

Publications:
Responsible Party: Linda Topjian, study coordinator, Lahey Clinic
ClinicalTrials.gov Identifier: NCT00872495     History of Changes
Other Study ID Numbers: 2002-061 
Study First Received: March 27, 2009
Last Updated: December 18, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
Urothelial Cancer
Cancer
Bladder Neoplasms
Urinary Bladder Cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on February 04, 2016