NCT00095589

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2004

Longer than P75 for all trials

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2004

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

4.8 years

First QC Date

November 5, 2004

Last Update Submit

February 6, 2019

Conditions

Bladder Cancer

Keywords

bladder cancerstage 0 bladder cancerstage I bladder cancertransitional cell carcinoma of the bladder

Interventions

loss of heterozygosity analysisGENETIC
microarray analysisGENETIC
microsatellite instability analysisGENETIC
cytology specimen collection procedureOTHER
laboratory biomarker analysisOTHER
computed tomographyPROCEDURE
cystoscopyPROCEDURE

Eligibility Criteria

Age40 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (13)

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

Location

Stanford Cancer Center

Stanford, California, 94305-5824, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Grand Strand Urology, LLP

Myrtle Beach, South Carolina, 29572, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Dan L. Duncan Cancer Center at Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Edmond Odette Cancer Centre at Sunnybrook

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Microarray AnalysisCystoscopy

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Mark P. Schoenberg, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2004

First Posted

November 8, 2004

Study Start

August 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations

US(12)CA(1)