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Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients

Sponsor
Genetron Health (Industry)
Overall Status
Completed
CT.gov ID
NCT05400018
Collaborator
Peking University Cancer Hospital & Institute (Other), Harbin Medical University (Other), Shanghai 10th People's Hospital (Other)
1,041
Enrollment
3
Locations
3.2
Actual Duration (Months)
347
Patients Per Site
108.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trail is to evaluate the performance of Genetron D842V PCR kit in GIST 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 Genetron D842V PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. The safety and effectiveness of this kit are confirmed and evaluated.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1041 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients
    Actual Study Start Date :
    Nov 20, 2020
    Actual Primary Completion Date :
    Feb 25, 2021
    Actual Study Completion Date :
    Feb 25, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Ct Value (Ct Values From PCR Reaction) [3 months]

      the number of PCR cycles where the amplification signal starts to be observed

    Secondary Outcome Measures

    1. PPV [3 months]

      the ratio of true positive in all positive cases

    2. NPV [3 months]

      the ratio of true negative in all negative cases

    3. Consistency (the Overall Ratio of True Positive and True Negative) [3 months]

      The overall consistency ratio of true positive and true negative, i.e. (true positive+true negative)/total number of cases

    4. Kappa coefficient [3 months]

      Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the Genetron D842V PCR kit and sanger sequencing method.

    Eligibility Criteria

    Criteria

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

    1. Paraffin-embedded tissue samples from patients clinically diagnosed with gastrointestinal stromal tumor (GIST), and a small number of other cancers or benign lesions in the gastrointestinal site were included as interference samples.

    2. The sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc.

    3. The sample is a formalin-fixed paraffin-embedded gastrointestinal stromal tumor tissue sample, and each sample can provide 5 paraffin sections or 5 paraffin rolls with a thickness of at least 5 µm.

    4. The content of tumor cells meets the requirements of assessment reagents and comparison methods.

    Exclusion Criteria:

    1. The investigator considers that it is not appropriate to continue the clinical trial, such as the samples that are not prepared according to the required steps.

    2. Samples that cannot complete the entire testing process.

    3. Patients with incomplete sample information.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Cancer Hospital Beijing China
    2 Harbin Medical University Cancer Hospital Harbin China
    3 Shanghai Tenth People's Hospital Shanghai China

    Sponsors and Collaborators

    • Genetron Health
    • Peking University Cancer Hospital & Institute
    • Harbin Medical University
    • Shanghai 10th People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Genetron Health
    ClinicalTrials.gov Identifier:
    NCT05400018
    Other Study ID Numbers:
    • 20200196
    First Posted:
    Jun 1, 2022
    Last Update Posted:
    Jun 6, 2022
    Last Verified:
    Jun 1, 2022
    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:
    Gastrointestinal Stromal Tumors

    Study Results

    No Results Posted as of Jun 6, 2022