Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients

Completed

• Conditions: Glioma, Mixed; Glioma, Malignant

• Registration Number: NCT05100173
• Lead Sponsor: Genetron Health

Brief 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.

Study Timeline

• Study Start: 2016-05-13
• Primary Completion: 2016-09-22
• Study Completion: 2016-12-08
• Status Verified: 2017-01
• Study First Submitted: 2021-10-19
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-10-29
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1192

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. Incomplete sample information
2. Severely contaminated samples
3. Samples that do not meet the requirements of sample collection and processing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of the Genetron IDH1 PCR Kit	3 months	The main purpose of this study is: by evaluating the Genetron IDH1 PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods.

Trial Locations

Locations (4)

The First Hospital of Jilin University; 🇨🇳 Jilin, China

West China Hospital of Sichuan University; 🇨🇳 Sichuan, China

Huashan Hospital of Fudan University; 🇨🇳 Shanghai, China

The Second Affiliated Hospital of Zhejiang University; 🇨🇳 Zhejiang, China