Bladder Cancer
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTUriFind Bladder Cancer Assay
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.
Sponsors
AnchorDx Medical Co., Ltd.
Specialty Networks
AnchorDx Medical Co. Ltd. US
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Clinical Validation Group: 1. 55 years or older, gender is not limited 2. Suspected of bladder cancer and are scheduled for bladder biopsy or trans-uretheral resection of bladder tumor (TUBRT) 3. Can receive standard of care, including urine cytology, cystoscopy, or surgery for bladder cancer diagnosis 4. Can provide at least of 75 ml of urine (prior to cystoscopy or surgery)
Exclusion criteria
1. History of urinary cancer 2. Neoadjuvant therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of UriFind assay in detecting early stage Bladder Cancer | Baseline | To evaluate the performance of the UriFind assay relative to the patient at diagnosis (cystoscopy or surgery followed by histology). |
Countries
United States
Outcome results
None listed