Viewing Study NCT05100602


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Study NCT ID: NCT05100602
Status: COMPLETED
Last Update Posted: 2021-11-22
First Post: 2021-10-20
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients
Sponsor: Genetron Health
Organization:

Study Overview

Official Title: Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients
Status: COMPLETED
Status Verified Date: 2017-01
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 TERT 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 the Genetron TERT 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 C228T and C250T mutations of TERT promoter genes in different subtypes was counted to evaluate the clinical application performance of the Genetron TERT PCR Kit.

Study Oversight

Has Oversight DMC: False
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?: