Trials / Completed
CompletedNCT05400018
Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,041 (actual)
- Sponsor
- Genetron Health · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this trail is to evaluate the performance of Genetron D842V PCR kit in GIST patients using real-time PCR method.
Detailed description
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron D842V PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. The safety and effectiveness of this kit are confirmed and evaluated.
Conditions
Timeline
- Start date
- 2020-11-20
- Primary completion
- 2021-02-25
- Completion
- 2021-02-25
- First posted
- 2022-06-01
- Last updated
- 2022-06-06
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05400018. Inclusion in this directory is not an endorsement.