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irAE Prediction of Anti-PD-1/L1 in Lung Cancer

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05288569
Collaborator
(none)
120
Enrollment
1
Location
30.1
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the purpose of this study is to identify multi-dimensional immunological biomarkers including cytokines, autoantibodies, and immune cell subtypes of immune-related adverse events (primary) and prognosis(secondary) in the anti-PD-1/anti-PD-L1 immunotherapy for lung cancer

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    After being informed of the study and potential risk, all patients giving written informed consent will undergo peripheral blood sample collection at baseline (before treatment ), 1month and 3month after treatment initiation, and when immune-related adverse events ever occur. The follow-up period will be 1 year for any occurrence of immune-related adverse events and 2 years follow-up for the prognosis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Immunological Biomarkers for Immune-related Adverse Events of Anti-PD-1/PD-L1 Immunotherapy in Lung Cancer: a Prediction Model
    Anticipated Study Start Date :
    Mar 1, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. occurrence of immune-related adverse event (irAE) [12 months since immunotherapy initiation]

      Any adverse events occured within 12 months since immunotherapy initiation will be independently evaluated by two clinicians to determine whether it is irAE and all the clinical characteristics of irAE will be documented

    Secondary Outcome Measures

    1. Overall Survival [24 months since immunotherapy initiation]

      Patients will be followed up for 2 years to investigate Overall Survival

    2. Progression Free Survival. [24 months since immunotherapy initiation]

      Patients will be followed up for 2 years to investigate Progression Free Survival.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18-80 years of age

    • Stage I-IV Lung Cancer confirmed by histopathology or imaging techniques

    • Receiving anti-PD-1/anti-PD-L1 immunotherapy (with indication and no contraindication)

    Exclusion Criteria:

    • Other cancer treatment

    • Other malignancies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing China

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Study Chair: Huaxia Yang, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05288569
    Other Study ID Numbers:
    • JS-2853
    First Posted:
    Mar 21, 2022
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking Union Medical College Hospital
    immunology
    biomarkers
    prediction
    multidimensional
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Apr 4, 2022