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Exploring Cancer Evolution, Prognostic and Predictive Biomarkers in EGFR-mutant NSCLC

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05997719
Collaborator
(none)
150
Enrollment
1
Location
88.8
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate genomic architecture, cancer evolution and their relationship with clinical outcomes in EGFR-mutant NSCLC.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    EGFR mutations are detected in about 50% of East Asian NSCLC and 10% of Western NSCLC. EGFR-mutant NSCLC harbors distinct genomic architecture including high ITH, early diversification, genome instability, low background mutation rates. But despite its high ITH, EGFR-mutant NSCLC usually have better prognosis than NSCLC with other driver mutations even without the application of targeted therapies, indicating that EGFR mutations may have distinct impacts on cancer evolution. This study intends to investigate the genomic architecture, cancer evolution trajectories and their relationship with clinical outcomes in EGFR-mutant NSCLC, and to identify prognostic and predictive biomarkers for this population that could potentially guide therapeutic decisions and improved clinical outcomes.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Exploring Cancer Evolution, Prognostic and Predictive Biomarkers in EGFR-mutant NSCLC
    Anticipated Study Start Date :
    Aug 8, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2028
    Anticipated Study Completion Date :
    Dec 31, 2030

    Outcome Measures

    Primary Outcome Measures

    1. Intratumor heterogeneity (ITH) [5 years]

      Intratumor heterogeneity in terms of genomic architecture, transcriptomic profiles and clonal composition; Investigate the relationship between ITH, clinical features and clinical outcomes in EGFR-mutant NSCLC

    Secondary Outcome Measures

    1. Clinical utility of ctDNA in EGFR-mutant NSCLC [5 years]

      Clinical utility of ctDNA in dissecting ITH, and its relationship with clinical features and clinical outcomes in EGFR-mutant NSCLC

    Eligibility Criteria

    Criteria

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

    1. Aged 18 years or older

    2. Histologically or cytologically confirmed non-small-cell lung cancer

    3. ECOG PS=0-2

    4. EGFR mutations confirmed by tissue or peripheral blood

    5. Can provide tumor tissue samples (fresh or archived)

    6. The subject should have good compliance, who would participate in the research voluntarily, and sign the informed consent

    Exclusion Criteria:

    1. History of other malignancies within 5 years (excluding basal cell carcinoma of the skin or other carcinoma in situ that has been resected).

    2. Unable to provide sufficient tumor tissue for analysis.

    3. Subjects with active, unstable systemic diseases, such as active infection, uncontrolled hypertension, heart failure (NYHA class >= II), unstable angina pectoris, acute coronary syndrome, severe arrythmia, severe liver, kidney or metabolic diseases, HIV infection.

    4. Subjects who are deemed unable to comply with the study requirements or complete the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen University Cancer Center Guanzhou China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Li Zhang, MD, Chief of Medical Oncology Department, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT05997719
    Other Study ID Numbers:
    • B2023-287-01
    First Posted:
    Aug 18, 2023
    Last Update Posted:
    Aug 18, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Li Zhang, MD, Chief of Medical Oncology Department, Sun Yat-sen University
    EGFR mutation
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Aug 18, 2023