Trials / Completed
CompletedNCT05100173
Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,192 (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 IDH1 PCR Kit in Glioma 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 IDH1 PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. Combined with the results of clinicopathological classification, the incidence of IDH1 gene R132H mutation in different subtypes was counted to evaluate the clinical performance of the Genetron IDH1 PCR Kit.
Conditions
Timeline
- Start date
- 2016-05-13
- Primary completion
- 2016-09-22
- Completion
- 2016-12-08
- First posted
- 2021-10-29
- Last updated
- 2021-11-22
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05100173. Inclusion in this directory is not an endorsement.