MDACC Study Summary 2007-0163

Study Summary
No. 2007-0163:.......Cancer Prevention......Jay B. Shah......Urology

Study Summary Title



Study Summary Number:	2007-0163

Study Title:	Screening for Bladder Cancer

Physician

New Patient Referral



Name:	Jay B. Shah	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:	Cancer Prevention	Supported By:	National Institutes of Health

Phase of Study:	N/A	Return Visit:	Participants will come to MDACC to enroll in the study, and receive instructions for home screening. If screening is positive for hematuria, an appointment will be made to see the physician and have further evaluation for bladder cancer.

Treatment Agents:	None	Home Care:	Participants will be given kits to test urine at home. Instructed to dip the Hemastix strip in their urine, daily as close to 10 consecutive days as possible the 1st month, and record the results. Repeat testing approximately 9 months later.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	No hospitalization will be required.


Description/ Intervention:	The goal of this clinical research study is to screen for blood in the urine of men who are at risk for developing bladder cancer. If blood does appear in the urine, researchers want to compare the results of 3 tests that are designed to detect cancer cells in urine.

Study Objectives / Outcomes

1. Estimate the proportion of individuals with a positive Hemastix test, versus those who have a positive Hemastix test and at least one positive marker test, who have a urothelial malignancy, other urinary tract malignancies or other serious diseases detected – the predictive value of a positive test.

2. Determine the incidence and prevalence of hematuria (alone or with either marker test being positive) and bladder cancer in the population screened by comparing results during the first testing period (prevalence cases) with those detected in the 2nd testing (incidence cases).

3. Determine the performances of each marker test together, in a variety of combinations, or alone in a population of microhematuria detected by dipstick.

4. Define the characteristics of populations which are most likely to have detectable hematuria-producing serious disease and to participate fully in future home screening programs by:

a. identifying correlates (social, demographic, medical history, medications, lifestyle, work and environmental exposures, and family factors) of hematuria and the cancers that can cause it.

b. identifying personal characteristics which correlate with initial and continued participation with regular compliance.

5. We will determine how often these marker tests detect other serious diseases in patients with microhematuria, including renal cancer.

Study Status Information



Study Activation / Registration Date:	10/15/2007

IRB Review and Approval Date:	10/15/2007

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	1500-2000

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) Men age 60 and over, who are either current cigarette smokers or who have a history of at least 20 pack years smoking

2) 75% or more of the enrollees at each study site will have a >/= 40 pack-year smoking history and

3) The Medical and Health Related Questionnaire will be reviewed for eligibility criteria and

4) Whenever possible, the volunteer's primary care physician should be contacted to determine their eligibility

Exclusion Criteria:

1) History of bladder cancer or

2) Individuals with hematuria or hematuria producing conditions (for example, anticoagulants such as Coumadin and Lovenox (ASA alone with or without Plavix is allowed), known active kidney or bladder stones, bacteruria, indwelling tubes or stents] or

3) Individuals with complex medical conditions not suitable for screening (for example, major neurologic, psychologic, or ophthalmologic diseases that make self-testing impractical) or

4) Individuals who will not be able to follow study instructions or

5) Females (Previous screening investigations have only studied men. The incidence of microscopic hematuria in women is unknown but is higher than in men and more likely to be associated with benign conditions. Including women would require significant increases in sample size and is beyond the resources of this NCI funded study.)

Links

Registration Number: NCT00848627
Study Information on Clinical Trials Registry (clinicaltrials.gov)