Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT05400018
Status:
COMPLETED
Last Update Posted:
2022-06-06
First Post:
2022-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients
Sponsor:
Genetron Health
Organization:
Study Overview
Official Title:
Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: