An observational study in Bladder Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 13 sites in 2 countries. Open to participants aged 40 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-08.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Observational
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
Secondary
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 125 is below the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Group 1 (healthy volunteers):
No suspected exposure to environmental bladder carcinogens for > 1 year, including, but not limited to, the following occupations or exposures:
Group 2 (participants with condition(s) that lead to false-positive urinary bladder cancer screening studies):
At least 1 of the following conditions:
GU infection (e.g., prostatitis, urinary tract infection, pyelonephritis, urethritis) within the past 3 months and completed treatment
Group 3 (superficial bladder cancer patients):
Histologically confirmed superficial bladder urothelial malignancy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No prior cancer except nonmelanoma dermatologic malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior chemotherapy
Endocrine therapy
Radiotherapy
Surgery
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins