Bladder Cancer Clinical Trial
Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay
Summary
The AnchorDx UriFind™ Bladder Cancer Assay is designed to detect 2 DNA methylation biomarkers in urine specimens from patients 22 years or older suspected of having bladder cancer. Results from the assay are intended for use, in conjunction with current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients.
Eligibility Criteria
Inclusion Criteria:
Clinical Validation Group:
22 years or older, gender is not limited
Suspected of bladder cancer (including hematuria, inflammatory bladder, suspicious ultrasound results)
Can receive standard of care, including urine cytology, cystoscopy, or surgery for bladder cancer diagnosis
Can provide at least of 100 ml of urine (prior to cystoscopy or surgery)
The assay specificity samples (some samples can overlap with non-cancer cases of the clinical validation group):
Healthy volunteers
Genitourinary benign diseases
Genitourinary cancer (non-bladder)
Non-Genitourinary benign diseases
Non-Genitourinary cancer
Exclusion Criteria:
1) History of urinary cancer 2) Neoadjuvant therapy
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