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Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients

NCT ID: NCT05100173

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-13

Study Completion Date

2016-12-08

Brief Summary

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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

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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.

Conditions

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Glioma, Malignant Glioma, Mixed

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

Genetron Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Hospital of Jilin University

Jilin, , China

Site Status

Huashan Hospital of Fudan University

Shanghai, , China

Site Status

West China Hospital of Sichuan University

Sichuan, , China

Site Status

The Second Affiliated Hospital of Zhejiang University

Zhejiang, , China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2016063011100922

Identifier Type: -

Identifier Source: org_study_id