CompletedNot Applicable

Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

United States, Canada125 participantsStarted 2004-08

Plain-language 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 participants, participants who have genitourinary conditions requiring cystoscopy, and patients who have bladder cancer.

Who can participate

Age range

40 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 carc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00095589

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2009-06

View on ClinicalTrials.gov More Bladder Cancer trials