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Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients

Sponsor
Genetron Health (Industry)
Overall Status
Completed
CT.gov ID
NCT05100602
Collaborator
Huashan Hospital (Other), Zhejiang University (Other), West China Hospital (Other), The First Hospital of Jilin University (Other)
1,192
Enrollment
4
Locations
6.9
Actual Duration (Months)
298
Patients Per Site
43.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1192 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients
    Actual Study Start Date :
    May 13, 2016
    Actual Primary Completion Date :
    Sep 22, 2016
    Actual Study Completion Date :
    Dec 8, 2016

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Hospital of Jilin University Jilin China
    2 Huashan Hospital of Fudan University Shanghai China
    3 West China Hospital of Sichuan University Sichuan China
    4 The Second Affiliated Hospital of Zhejiang University Zhejiang China

    Sponsors and Collaborators

    • Genetron Health
    • Huashan Hospital
    • Zhejiang University
    • West China Hospital
    • The First Hospital of Jilin University

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Genetron Health
    ClinicalTrials.gov Identifier:
    NCT05100602
    Other Study ID Numbers:
    • 2016063011442779
    First Posted:
    Oct 29, 2021
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glioma

    Study Results

    No Results Posted as of Nov 22, 2021