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

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ClinicalTrials.gov Identifier: NCT00872495

Recruitment Status : Recruiting

First Posted : March 31, 2009

Last Update Posted : January 11, 2018

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Linda Topjian, Lahey Clinic

Study Description

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

Show Detailed Description

Study Design


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

Genetics Home Reference related topics: Bladder cancer

MedlinePlus related topics: Bladder Cancer Urine and Urination

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.

Group/Cohort

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.

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted:	March 31, 2009 Key Record Dates
Last Update Posted:	January 11, 2018
Last Verified:	January 2018

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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