Test for detecting bladder cancer using urine samples
A Multicenter, Single-blind, Prospective Clinical Trial to Evaluate the Clinical Performance of EarlyTect® Bladder Cancer Test in the Urine DNA for Detecting Bladder Cancer Among Hematuria Patients
This study is testing a new urine test for bladder cancer in people over 40 who have blood in their urine to see if it works better than current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1549 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05220189 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the sensitivity and specificity of the EarlyTect® Bladder Cancer test in patients with hematuria by comparing its results to cystoscopy examinations. Participants aged 40 and older with recent hematuria will provide urine samples for the EarlyTect® test, as well as undergo NMP22 and urine cytology tests. The study will also confirm the diagnosis of bladder lesions through histopathological examination following cystoscopy. The goal is to determine the effectiveness of the EarlyTect® test in identifying bladder cancer compared to existing diagnostic methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older who have experienced hematuria within the last three months and are scheduled for cystoscopy.
Not a fit: Patients with a history of bladder cancer or upper tract urothelial cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this test could provide a non-invasive and accurate method for early detection of bladder cancer in patients with hematuria.
How similar studies have performed: Other studies have explored similar methylation biomarker approaches for cancer detection, showing promising results, but this specific test is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals who agree to voluntarily sign an informed consent prior to the initiation of screening * Adults aged ≥40 * Subjects who have had gross or microscopic hematuria within the 3 months * Subjects who had no history of bladder cancer and upper tract urothelial cancer * Subjects who will undergo cystoscopy, NMP22 test, and urine cytology within 1 month after consent Exclusion Criteria: * Individuals who do not agree to voluntarily sign an informed consent prior to the initiation of screening * Subjects aged \<40 years * Subjects with a history of bladder cancer and upper tract urothelial cancer * Female who are currently menstruating or who have had their last menstrual period within the last 3 days * Subjects who have undergone invasive procedures in the urinary tract system within the last 3 months * Subjects with suspected upper urothelial cancer lesions on ultrasound or CT scan * Subjects who have previously received pelvic radiation therapy * Subjects who have been diagnosed with other cancers and have received or are currently receiving chemotherapy or immunotherapy within 6 months * Subjects who require treatment for an active urinary tract infection or vaginitis * Subjects undergoing prostate cancer treatment or requiring a prostate biopsy * Subject has any condition which, in the opinion of the investigator should preclude participation in the study
Where this trial is running
Seoul
- Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Cheol Kwak, MD PhD — Seoul National University Hospital
- Study coordinator: Cheol Kwak, MD PhD
- Email: mdrafael@snu.ac.kr
- Phone: 82-2-2072-0817
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.