Trials / Unknown
UnknownNCT05180305
A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- TSH Biopharm Corporation Limited · Industry
- Sex
- Male
- Age
- 45 Years
- Healthy volunteers
- —
Summary
To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) comparing to prostate biopsy within the intended use population.
Detailed description
To determine the clinical performance of a blood-based test for clinically significant (CS) prostate cancer (PCa) (grade group ≥ 2) intended for use in men with prostate serum antigen levels in the 'grey zone' (PSA \< 10 ng/ml). The test quantifies a previously described 3.4 kb mitochondrial DNA (mtDNA) deletion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Mitomic Prostate Test | Mitomic Prostate Test |
Timeline
- Start date
- 2021-04-27
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2022-01-06
- Last updated
- 2022-01-06
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT05180305. Inclusion in this directory is not an endorsement.