Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients

Glioma, Malignant Clinical Trial

Official title:

Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05100173
• Other study ID #: 2016063011100922
• Status: Completed
• Start date: May 13, 2016
• Est. completion date: December 8, 2016

Study information

• Verified date: January 2017
• Source: Genetron Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1192
• Est. completion date: December 8, 2016
• Est. primary completion date: September 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Glioma, Malignant
• Glioma, Mixed

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Jilin
China	Huashan Hospital of Fudan University	Shanghai
China	West China Hospital of Sichuan University	Sichuan
China	The Second Affiliated Hospital of Zhejiang University	Zhejiang

Sponsors (5)

Lead Sponsor	Collaborator
Genetron Health	Huashan Hospital, The First Hospital of Jilin University, West China Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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