Study on Risk Assessment for Patients With Microscopic Hematuria (Non-Visible Blood in Urine) Using a Urine Marker Test

N/ANot Yet RecruitingNCT07307300

Christian Bolenz1,475 enrolled

Overview

The goal of this clinical study is to learn how well a urine test called Xpert® Bladder Cancer Detect (Xpert BC-D) can help doctors assess the risk of bladder cancer in people with non-visible blood in their urine (microscopic hematuria). The main questions it aims to answer are: * Can the Xpert BC-D test accurately identify people at higher risk for bladder cancer? * Can combining the test results with other clinical information improve risk assessment compared to standard evaluation methods? Participants will: * Have leftover urine from the routine initial evaluation tested with the Xpert® Bladder Cancer Detect assay * Complete questionnaires about urinary symptoms using the modified IPSS and ICIQ-FLUT-S forms * Attend a first visit for medical evaluation and cystoscopy * Attend a follow-up visit 3 to 6 months later for additional testing and questionnaires This study includes adults over 40 years of age who have had microscopic hematuria detected within the past six months. People with a history of bladder cancer, urinary tract surgery, or certain other medical conditions, as well as individuals who are currently pregnant, cannot participate. The study will be conducted at 20-24 sites in Germany and Austria and will last approximately 27 months, with each participant involved for about 6 months. The results of this study may help doctors better decide which patients need further invasive testing, potentially reducing unnecessary procedures.

Study Type

OBSERVATIONAL

Enrollment

1,475

Conditions

Hematuria

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed consent form after being informed about the study * Willing and able to follow the study requirements * Non-visible blood in the urine, found within the past 6 months * Age over 40 years Exclusion Criteria: * Previous diagnosis of bladder cancer * Too much protein in the urine (shown by urine test) * Current urinary tract infection (symptoms like pain or frequent urination, plus bacteria found in urine test) * Current pain in the urinary tract or lower belly, pain score greater than 2 on a 0-10 scale * Signs of kidney-related blood in the urine (found by special urine test) * Bladder examination with a camera (cystoscopy) within the past 12 months * Pregnancy * Visible blood in the urine within the past year * Previous surgery on the urinary tract * Previous radiation treatment to the pelvic area * Permanent tube or foreign body in the urinary tract (such as a catheter) * Participation in another clinical study at the same time or within 30 days before this study * Detained under legal or official authority * Medical, psychological, or social problems that would make it hard to follow the study requirements * Not able to understand the study information well enough to give consent

Outcomes

Primary Outcomes

Validating results of a recent metanalysis (UroDetect II) achieving an overall sensitivity of the Xpert BC-D for UCas of >0.70 and a specificity of >0.65