Phase
Condition
Nephropathy
Bladder Cancer
Urothelial Cancer
Treatment
Cxbladder Triage Plus
Cxbladder Detect+
Clinical Study ID
Ages 18-88 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient is referred for assessment of microhematuria (MH) with presentationconfirmed by urine microscopy of 3 or more red blood cells per high powered field (RBC/HPF) (documented by the referring physician or at the investigator site) within 6-months of enrollment.
Physically able to provide a voided urine sample from a bladder that has not beensurgically altered.
Able to give informed, written consent.
Able and willing to comply with study requirements.
Must be 19 or the legal age of consent in the jurisdiction in which the study istaking place to 88 years of age inclusive, at the time of signing the informedconsent.
Ability to comprehend written and spoken English sufficiently to independentlyfollow all study procedures. Or ability to comprehend Spanish with access to anEnglish-Spanish interpreter for all study related verbal instructions anddiscussions.
Exclusion
Exclusion Criteria:
Prior history of bladder malignancy.
Prior history of upper tract UC or prostatic urethral UC.
Gross hematuria within the last twelve months (reported in patient's records and/orduring patient's interview)
Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit,Indiana pouch)
Indication to recommend cystoscopy other than MH (e.g., bothersome benign prostatichyperplasia symptoms and desires a procedure, weak stream with concerns for urethralstricture).
Cystoscopy contraindicated due to another condition or anatomy.
History of pelvic radiation.
Currently receiving systemic chemotherapy or has had systemic chemotherapy withinthe last 6 weeks.
History of schistosomiasis.
History of chronic (>3 months) indwelling Foley catheter or chronic (>3 months)bladder stones.
Known current pregnancy
Study Design
Connect with a study center
Urology Centers of Alabama
Homewood, Alabama 35209
United StatesSite Not Available
Urology Associates of Mobile
Mobile, Alabama 36608
United StatesSite Not Available
Urology Centers of Alabama
Homewood 4067927, Alabama 4829764 35209
United StatesActive - Recruiting
Urology Associates of Mobile
Mobile 4076598, Alabama 4829764 36608
United StatesActive - Recruiting
Advanced Urology Institute - Daytona Beach
Daytona Beach 4152872, Florida 4155751 32114
United StatesActive - Recruiting
Urologic Specialists of Northwest Indiana
Merrillville 4923482, Indiana 4921868 46410
United StatesActive - Recruiting
Southern Urology
Lafayette 4330145, Louisiana 4331987 70508
United StatesActive - Recruiting
Chesapeake Urology Research Associates
Hanover, Maryland 21076
United StatesSite Not Available
Chesapeake Urology Research Associates
Hanover 4357340, Maryland 4361885 21076
United StatesActive - Recruiting
Summit Health
Voorhees, New Jersey 08043
United StatesSite Not Available
Summit Health
Voorhees Township 5105860, New Jersey 5101760 08043
United StatesActive - Recruiting
Albany MED Health System
Albany, New York 12208
United StatesSite Not Available
Premier Medical Group of the Hudson Valley, P. C.
Poughkeepsie, New York 12601
United StatesSite Not Available
Albany MED Health System
Albany 5106834, New York 5128638 12208
United StatesActive - Recruiting
Integrated Medical Professionals
New York 5128581, New York 5128638 11042
United StatesActive - Recruiting
Premier Medical Group of the Hudson Valley, P. C.
Poughkeepsie 5132143, New York 5128638 12601
United StatesActive - Recruiting
Penn State Medical Center, Urology Research
Hershey, Pennsylvania 17033
United StatesSite Not Available
Penn State Medical Center, Urology Research
Hershey 5193342, Pennsylvania 6254927 17033
United StatesActive - Recruiting
Urology Associates, P. C.
Nashville, Tennessee 37209
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesActive - Recruiting
Urology Associates, P. C.
Nashville 4644585, Tennessee 4662168 37209
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
United StatesActive - Recruiting
UT Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390
United StatesActive - Recruiting
University of Wisconsin-Madison
Madison, Wisconsin 53792
United StatesSite Not Available
University of Wisconsin-Madison
Madison 5261457, Wisconsin 5279468 53792
United StatesActive - Recruiting

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