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Clinical Evaluation of Genetron TERT/BRAF PCR Kit in Thyroid Cancer Patients

Sponsor
Genetron Health (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05395429
Collaborator
Tianjin Medical University Cancer Institute and Hospital (Other), First Affiliated Hospital, Sun Yat-Sen University (Other), Yunnan Cancer Hospital (Other), The First Affiliated Hospital of Kunming Medical College (Other)
1,000
Enrollment
4
Locations
8.7
Anticipated Duration (Months)
250
Patients Per Site
28.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trail is to evaluate the performance of Genetron TERT/BRAF PCR Kit in Thyriod Cancer 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 TERT/BRAF 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
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Clinical Evaluation of Genetron TERT/BRAF PCR Kit in Thyroid Cancer Patients
    Actual Study Start Date :
    Mar 25, 2022
    Anticipated Primary Completion Date :
    Nov 15, 2022
    Anticipated Study Completion Date :
    Dec 15, 2022

    Outcome Measures

    Primary Outcome Measures

    1. The main purpose of this study is: by evaluating the Genetron TERT/BRAF PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods. [2 months]

    Eligibility Criteria

    Criteria

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

    1. Patients with clinical diagnosis of suspected thyroid cancer who underwent fine-needle aspiration (FNA)

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

    3. Subjects who can provide a complete FNA sample

    4. Subjects who agree to provide follow-up diagnosis and treatment information

    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 with incomplete information required.

    3. The amount of DNA extracted is not enough to complete the samples tested by the assessment reagent or comparative method.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First Affiliated Hospital, Sun Yat-Sen University Guangzhou China
    2 First Affiliated Hospital of Kunming Medical University Kunming China
    3 Tianjin Medical University Cancer Institute and Hospital Tianjin China
    4 Yunnan Cancer Hospital Yunnan China

    Sponsors and Collaborators

    • Genetron Health
    • Tianjin Medical University Cancer Institute and Hospital
    • First Affiliated Hospital, Sun Yat-Sen University
    • Yunnan Cancer Hospital
    • The First Affiliated Hospital of Kunming Medical College

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Genetron Health
    ClinicalTrials.gov Identifier:
    NCT05395429
    Other Study ID Numbers:
    • 20210155
    First Posted:
    May 27, 2022
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    May 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:
    Thyroid Neoplasms
    Thyroid Diseases

    Study Results

    No Results Posted as of Jun 3, 2022