Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients

The purpose of this trail is to evaluate the performance of Genetron IDH1 PCR Kit in Glioma patients using real-time PCR method.

Study Overview

• Status: Completed
• Conditions: Glioma, Malignant; Glioma, Mixed

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 Type: Observational
• Enrollment (Actual): 1192

Contacts and Locations

Study Locations

• China
  • Jilin, China
    • The First Hospital of Jilin University
  • Shanghai, China
    • Huashan Hospital of Fudan University
  • Sichuan, China
    • West China Hospital of Sichuan University
  • Zhejiang, China
    • The Second Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospital sample

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the Genetron IDH1 PCR Kit	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.	3 months

Collaborators and Investigators

• Sponsor: Genetron Health
• Collaborators: Huashan Hospital; West China Hospital; The First Hospital of Jilin University; Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2016
• Primary Completion (Actual): September 22, 2016
• Study Completion (Actual): December 8, 2016

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: 2016063011100922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No