Bladder CancerNCT00095589
Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer
An observational study of Bladder Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 13 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- loss of heterozygosity analysis, microarray analysis and microsatellite instability analysis
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Aug 2004to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, 35294
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, 77030
Grand Strand Urology, LLP
Myrtle Beach, South Carolina, 29572
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
Stanford Cancer Center
Stanford, California, 94305-5824
Canada1 site
Edmond Odette Cancer Centre at Sunnybrook
Toronto, Ontario, M4N 3M5
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Bladder Cancer
- Being tested
- loss of heterozygosity analysis, microarray analysis, microsatellite instability analysis, cytology specimen collection procedure, laboratory biomarker analysis
- Keywords
- bladder cancer, stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loss of heterozygosity analysisGenetic
microarray analysisGenetic
microsatellite instability analysisGenetic
cytology specimen collection procedureOther
laboratory biomarker analysisOther
computed tomographyProcedure or surgery
cystoscopyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2004 (estimated)
- Study startAug 2004
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark P. Schoenberg, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095589
- Sponsor's protocol ID
- J0382
- Other IDs
- U01CA084968, P30CA006973, 03-12-30-05, CDR0000401496
- Status last verified
- Feb 2019
- First submitted
- 5 Nov 2004
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study
- ClinicalTrials.gov ID
- NCT00095589
- Acronym / sponsor ID
- J0382
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 8 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| loss of heterozygosity analysis | Genetic | – |
| microarray analysis | Genetic | – |
| microsatellite instability analysis | Genetic | – |
| cytology specimen collection procedure | Other | – |
| laboratory biomarker analysis | Other | – |
| computed tomography | Procedure or surgery | – |
| cystoscopy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark P. Schoenberg, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.