MDACC Study Summary 2004-0051 (Archived)

Study Summary
No. 2004-0051:.......Bladder......Ashish M. Kamat......Urology

Study Summary Title



Study Summary Number:	2004-0051

Study Title:	Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment

Physician

New Patient Referral



Name:	Ashish M. Kamat	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Urology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-3250 Contact us about clinical trials

General Information



Disease Group:	Bladder	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Group 3 (Patients with Bladder Cancer) will have urine and blood samples and cystoscopy with follow up Medical History every 3 months for 24 months.

Treatment Agents:	None	Home Care:	None

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Patient may stay overnight after Cytoscopy, but it is not required by study.


Description/ Intervention:	The goal of this clinical research study is to develop a new test to help doctors detect bladder cancer in urine.

Study Objectives / Outcomes

Goals

Goal 1

: To determine sensitivity and specificity of microsatellite analysis (MSA) of urine sediment, using a panel of 14 microsatellite markers,

in detecting bladder cancer in participants requiring cystoscopy. This technique will be compared to the diagnostic standard of cystoscopy, as well as to urine cytology.

Goal 2:

To determine the temporal performance characteristics of microsatellite analysis of urine sediment.

Goal 3

: To determine which of the 14 individual markers or combination of markers that make up the MSA test are most predictive of the presence of bladder cancer.

Specific Aims

Aim 1

: This study will test the specificity of MSA in two groups of participants without bladder cancer─both healthy, normal controls─as well as participants without bladder cancer who have conditions known to confound the performance of previous urinary tests for bladder cancer.

Aim 2:

This study will test the sensitivity of MSA in the presence of clinically evident, pathologically confirmed bladder cancer.

Aim 3

: This study will test the sensitivity and specificity of MSA for the detection of bladder cancer among participants undergoing surveillance for bladder cancer.

Aim 4

: This study will test the value of MSA to predict subsequent development of bladder cancer among participants with a history of bladder cancer.

Study Status Information



Study Activation / Registration Date:	08/16/2004

IRB Review and Approval Date:	08/16/2004

Study Type:

Recruitment Status:	Terminated

Projected Accrual:	Total accrual will be: 500

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Endoscopic evidence confirmed by biopsy consistent with a superficial bladder urothelial malignancy

2) Age >/= 40

3) No history or current evidence of GU malignancy (prosate, kidney or penile)

4) No history of other cancer with the initial diagnosis being within the past 5 years (except non-melanoma dermatologic malignancy and bladder cancer)

5) No history of chemotherapy or radiotherapy for cancer within past 5 years

6) Agree to participate in the 2-year follow-up period, or standard of care follow-up for their condition

7) Signed the informed consent document

8) All lab results and procedures must be obtained and dated on or up to 6 weeks (42 days) after the date of consent. The only exception to the rule if for Urine Cytology, which may be dated up to 6 weeks (42 days) prior to the date of consent

Exclusion Criteria:

1) Previous history of radiotherapy or systemic chemotherapy (other than intravesical therapy for bladder cancer) within the past 5 years

2) Non-transitional cell carcinoma of the bladder, upper tract tumors, muscle-invasive tumors or superficial disease for which local therapy is not appropriate

3) History of GU cancer (prostate, kidney or penile)

4) History of other cancer with thte initial diagnosis within the past 5 years (except non-melanoma dermatologic malignancy and bladder cancer)

5) Lab results or procedures not completed within the specified timeframe

Links

Registration Number: NCT00095589
Study Information on Clinical Trials Registry (clinicaltrials.gov)