Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients

Genetron Health

Status: Completed

Conditions: Glioma, Malignant

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05100602

2016063011442779

Details and patient eligibility

About

The purpose of this trail is to evaluate the performance of Genetron TERT PCR Kit in Glioma patients using real-time PCR method.

Full 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.

Enrollment: 1,192 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Enroll cases in strict accordance with the requirements of the study
2. The remaining samples after routine clinical testing
3. The collection and processing of samples meet the requirements of standard laboratory operations and product instructions
4. The relevant information of the sample is complete, including sample number, gender, age, and possible clinical diagnosis information
5. Each sample must have HE staining results (hematoxylin-eosin staining)
6. Pathological examination diagnosed as glioma, other brain tumors or normal tissues
7. Number of samples: 10 pieces of each sample with a thickness of 10μm, and the tumor content is not less than 50%

Exclusion criteria

1. The sample information is not complete
2. Severely contaminated samples
3. Samples that do not meet the requirements of sample collection and processing

Trial design