Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05100602

Enrollment

1192

Registered

2021-10-29

Start date

2016-05-13

Completion date

2016-12-08

Last updated

2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma, Malignant

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of the Genetron TERT PCR Kit	3 months	The main purpose of this study is: by evaluating the Genetron TERT PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods.

Countries

China

Outcome results