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LC_Biomarker: Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy

Sponsor
Se-Hoon Lee (Other)
Overall Status
Unknown status
CT.gov ID
NCT03578185
Collaborator
(none)
800
Enrollment
3
Locations
32.7
Anticipated Duration (Months)
266.7
Patients Per Site
8.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to identify the predictive biomarker for immunotherapy using patient samples (tumor tissue, blood, fecal material) who treated with immune checkpoint inhibitor.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    [Sample acquisition]

    • Informed consent is waived for those who agree to donate samples left over from other clinical trials or acquired for other purposes to be used for other research by the sign to master agreement in advance.

    • The study will be conducted based on the purposes indicated in the master agreement signed by tissue donator [Clinical data acquisition]

    • Baseline demographics: Sex, Birth date, expire date (last follow-up date for the survivals)

    • Lung cancer treatment history: diagnosed date, treatment history (surgery, radiation therapy, chemotherapy, immunotherapy treatment history, and responses), general performance, metastatic sites

    • Lung cancer histologic information: pathology, histologic subtype, EGFR mutation profile, ALK-rearrangement result

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy
    Actual Study Start Date :
    Apr 11, 2018
    Anticipated Primary Completion Date :
    Dec 31, 2020
    Anticipated Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. List of biomarkers [Baseline]

      Neoantigen, tumor mutation burden, MHC compatibility, T-cell receptor and associated immune gene signature (IFN-r, interferons such as IL-2 and interleukin family), T-cell subset (T cell surface marker such as CD4+, CD7+, CD8+, CD16, CD34+, CD38+, CD56+, etc.), PD-1/PD-L1 expression, etc.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. aged above or equal to 18

    2. Histologically confirmed lung cancer patients

    3. Patient treated with immune checkpoint inhibitor

    Exculsion Criteria:

    NA

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Gangnam-gu Korea, Republic of
    2 Seoul National University Hospital Seoul Joungro-gu Korea, Republic of
    3 Asan Medical Center Seoul Songpa-gu Korea, Republic of

    Sponsors and Collaborators

    • Se-Hoon Lee

    Investigators

    • Study Chair: Se-hoon Lee, MD, Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Se-Hoon Lee, Professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT03578185
    Other Study ID Numbers:
    • Lung cancer Biomarker_2018
    First Posted:
    Jul 6, 2018
    Last Update Posted:
    Mar 25, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 25, 2020