Evaluation of Non-Invasive Assay(s) for the Detection of Bladder Cancer - Full Text View

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 bladder cancer progression. This analysis may be helpful to determine if how a particular cancer will act regarding remission and recurrence

Condition
Bladder 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 Assay(s) for the Detection of Bladder Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer Urine and Urination

U.S. FDA Resources

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.

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 cystectomy or 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

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

Contacts

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

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: 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.

Sponsors and Collaborators

Lahey Clinic

Investigators

Principal Investigator:

John A. Libertino, M.D.

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:	John A. Libertino, M.D., Lahey Clinic, Inc.
ClinicalTrials.gov Identifier:	NCT00872495 History of Changes
Other Study ID Numbers:	2002-061
Study First Received:	March 27, 2009
Last Updated:	June 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Lahey Clinic:

Bladder Cancer
Cancer
Bladder Neoplasms
Urinary Bladder Cancer

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms

Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013