Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer



Status:Completed
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - 120
Updated:2/10/2019
Start Date:August 2004
End Date:June 2009

Use our guide to learn which trials are right for you!

Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study

RATIONALE: New diagnostic procedures such as microsatellite analysis of sediment in the urine
may improve the ability to detect bladder cancer without invasive procedures.

PURPOSE: Diagnostic trial to study the effectiveness of microsatellite analysis of sediment
in the urine in detecting bladder cancer in healthy participants, participants who have
genitourinary conditions requiring cystoscopy, and patients who have bladder cancer.

OBJECTIVES:

Primary

- Compare the sensitivity and specificity of microsatellite analysis (MSA) of urine
sediment with cystoscopy and urine cytology for detecting bladder cancer in participants
undergoing cystoscopy.

Secondary

- Determine the temporal performance characteristics of MSA in urine sediment from these
participants.

- Determine which of the 15 individual markers or combination of markers that make up the
MSA test are most predictive of the presence of bladder cancer in these participants.

OUTLINE: This is a single-blind, multicenter, cohort study.

Urine and blood specimens are collected from all participants at baseline. Urine specimens
are examined using microsatellite analysis, urine cytology, and urinalysis. Patients in
groups 2 and 3 also undergo cystoscopy at baseline.

Patients in group 3 undergo cystoscopy, upper tract imaging (e.g., abdominal CT scan),
microsatellite analysis, urine cytology, and urinalysis every 3 months for 2 years in the
absence of progressive disease.

Microsatellite analysis, which identifies loss of heterozygosity using polymerase chain
reaction technique, is conducted for 15 markers: D4S243, D21S1245, FGA, D17S695, D16S476,
D9S171, IFN-A, D20S48, D13S802, D17S654, D16S310, THO1, D9S162, D9S747, and MBP.

PROJECTED ACCRUAL: A total of 500 participants (100 each for groups 1 and 2 and 300 for group
3) will be accrued for this study.

DISEASE CHARACTERISTICS:

- Group 1 (healthy volunteers):

- No prior or concurrent urologic disease or devices

- No genitourinary (GU) complaints, including urgency or frequency of urination

- Normal urinalysis and urine cytology

- Never smoked cigarettes regularly (i.e., ≥ 1 cigarette/day for ≥ 1 year)

- No suspected exposure to environmental bladder carcinogens for > 1 year,
including, but not limited to, the following occupations or exposures:

- Aluminum industry

- Aromatic amines

- Coal gasification

- Coal tars and pitches

- Coke plant

- Dye industry

- Leather industry

- Machinist

- Painter

- Rubber industry

- Truck, bus, or taxi drivers

- Group 2 (participants with condition(s) that lead to false-positive urinary bladder
cancer screening studies):

- GU complaints requiring cystoscopy

- No current GU malignancy

- At least 1 of the following conditions:

- Benign prostatic hypertrophy (International Prostate Symptom Score > 12)

- Foreign bodies (stones, stents, or catheters)

- Hematuria (gross or microscopic)

- GU infection (e.g., prostatitis, urinary tract infection, pyelonephritis,
urethritis) within the past 3 months and completed treatment

- No sign of infection at the time of study participation

- Group 3 (superficial bladder cancer patients):

- Histologically confirmed superficial bladder urothelial malignancy

- Primary or recurrent disease

- No nontransitional cell carcinoma of the bladder, upper tract tumors,
muscle-invasive tumors, or superficial disease for which local therapy is not
appropriate

PATIENT CHARACTERISTICS:

Age

- Over 40

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- See Disease Characteristics

Other

- No prior cancer except nonmelanoma dermatologic malignancy

- Prior bladder cancer allowed for group 3 patients

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

- Prior intravesical therapy for bladder cancer allowed for group 3 patients

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy

Surgery

- Not specified
We found this trial at
13
sites
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-5830
James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
?
mi
from
Myrtle Beach, SC
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
Stanford, California 94305
?
mi
from
Stanford, CA
Click here to add this to my saved trials
?
mi
from
Toronto,
Click here to add this to my saved trials