Clincosm LogoSign in Get a demo

To Evaluate the Correlation Between the Results of Specific Gene Testing and the Efficacy of Targeted Therapy in Patients With NSCLC

Sponsor
Hunan Province Tumor Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05805267
Collaborator
(none)
130
Enrollment
1
Location
6.1
Actual Duration (Months)
21.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluated the correlation between the qualitative test results of Xiamen Aide the gene test specified by the test reagent and the efficacy of relevant targeted drugs in patients with non-small cell lung cancery, and the research data is used to support the registration and marketing of the assessment reagent

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    130 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    To Evaluate the Correlation Between the Results of Specific Gene Testing and the Efficacy of Targeted Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)
    Actual Study Start Date :
    Sep 20, 2022
    Actual Primary Completion Date :
    Feb 25, 2023
    Actual Study Completion Date :
    Mar 25, 2023

    Outcome Measures

    Primary Outcome Measures

    1. PFS [2 year]

      Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)

    Secondary Outcome Measures

    1. ORR [2 years]

      Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • 1)≥18;

      1. advanced non-small cell lung cancer confirmed by histopathology;
      1. Patients with NSCLC who have previously or are taking gefitinib (first-line therapy) or osimertinib (post-TKI resistance) or crizotinib monotherapy, and the response to treatment can be assessed;
      1. Have sufficient FFPE tissue samples within 5 years: 5 large specimens/case; There were 10 puncture specimens/case
    Exclusion Criteria:
      1. Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;

    • 2)Maintenance therapy if the disease does not progress after treatment with other antitumor methods

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hunan Cancer hospital Changsha Hunan China

    Sponsors and Collaborators

    • Hunan Province Tumor Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yongchang Zhang, Director, Head of Medical Oncology, Principal Investigator, Clinical Professor, Hunan Province Tumor Hospital
    ClinicalTrials.gov Identifier:
    NCT05805267
    Other Study ID Numbers:
    • CONFIDENCE II
    First Posted:
    Apr 7, 2023
    Last Update Posted:
    Apr 7, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Apr 7, 2023