Trials / Unknown
UnknownNCT04948528
Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma Detection
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 490 (estimated)
- Sponsor
- AnchorDx Medical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Clinical trial to determine the efficacy (sensitivity and specificity) of Anchordx's urine DNA methylation/somatic mutation assay for detecting upper tract urothelial carcinoma compared to pathology in patients.
Detailed description
This is a prospective study that involves 8 centers in China and 490 participants. The test analyzes the DNA methylation/somatic mutation profiles of urothelial cancer-specific biomarkers non-invasively using urine specimens collected before invasive diagnosis/treatment. The efficacy (sensitivity and specificity) of the assay for detection of upper tract urothelial carcinoma is evaluated in comparison to pathology or cystoscopy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Active Comparator: Surgery Pathology or Cystoscopy | Case group will be followed up with surgery pathology or cystoscopy. |
| OTHER | Active Comparator: Clinical Diagnosis | Control group will be diagnosed in clinical. |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2023-06-25
- Completion
- 2023-12-31
- First posted
- 2021-07-02
- Last updated
- 2023-05-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04948528. Inclusion in this directory is not an endorsement.