Clinical trial · Observational
Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay
Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay in Subjects Suspected of Having Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Protocol amendment.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UriFind Bladder Cancer Assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Clinical Validation Group
- description
- Patients with suspected bladder cancer (including hematuria, inflammatory bladder, suspicious ultrasound results)
- interventionNames
- Diagnostic Test: UriFind Bladder Cancer Assay
Primary outcomes (1)
- measure
- Sensitivity and Specificity of UriFind assay in detecting early stage Bladder Cancer
- timeFrame
- Baseline
- description
- To evaluate the performance of the UriFind assay relative to the patient at diagnosis (cystoscopy or surgery followed by histology).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available