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

This study is currently recruiting participants.

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Contacts and Locations

Verified September 2016 by Linda Topjian, Lahey Clinic

Sponsor:

ClinicalTrials.gov Identifier:

NCT00872495

First Posted: March 31, 2009

Last Update Posted: September 7, 2016

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.

Information provided by (Responsible Party):

Linda Topjian, Lahey Clinic

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:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Urine and Urination

U.S. FDA Resources

Further study details as provided by Linda Topjian, 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 ]

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.

Groups/Cohorts

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.

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Eligibility

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.


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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

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 ClinicalTrials.gov identifier (NCT number): 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:

Sidransky D, Von Eschenbach A, Tsai YC, Jones P, Summerhayes I, Marshall F, Paul M, Green P, Hamilton SR, Frost P, et al. Identification of p53 gene mutations in bladder cancers and urine samples. Science. 1991 May 3;252(5006):706-9.

Levesque P, Ramchurren N, Saini K, Joyce A, Libertino J, Summerhayes IC. Screening of human bladder tumors and urine sediments for the presence of H-ras mutations. Int J Cancer. 1993 Nov 11;55(5):785-90.

Fitzgerald JM, Ramchurren N, Rieger K, Levesque P, Silverman M, Libertino JA, Summerhayes IC. Identification of H-ras mutations in urine sediments complements cytology in the detection of bladder tumors. J Natl Cancer Inst. 1995 Jan 18;87(2):129-33.

Rieger-Christ KM, Mourtzinos A, Lee PJ, Zagha RM, Cain J, Silverman M, Libertino JA, Summerhayes IC. Identification of fibroblast growth factor receptor 3 mutations in urine sediment DNA samples complements cytology in bladder tumor detection. Cancer. 2003 Aug 15;98(4):737-44. Erratum in: Cancer. 2003 Nov 1;98(9):2000.


Responsible Party:	Linda Topjian, study coordinator, Lahey Clinic
ClinicalTrials.gov Identifier:	NCT00872495 History of Changes
Other Study ID Numbers:	2002-061
First Submitted:	March 27, 2009
First Posted:	March 31, 2009
Last Update Posted:	September 7, 2016
Last Verified:	September 2016

Keywords provided by Linda Topjian, Lahey Clinic:


Urothelial Cancer Cancer Bladder Neoplasms Urinary Bladder Cancer

Additional relevant MeSH terms:


Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site	Neoplasms Urinary Bladder Diseases Urologic Diseases

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