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

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

Detailed Description
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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.

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

Conditions
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Non-small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older Histologically or cytologically confirmed non-small-cell lung cancer ECOG PS=0-2 EGFR mutations confirmed by tissue or peripheral blood Can provide tumor tissue samples (fresh or archived) The subject should have good compliance, who would participate in the research voluntarily, and sign the informed consent Exclusion Criteria: History of other malignancies within 5 years (excluding basal cell carcinoma of the skin or other carcinoma in situ that has been resected). Unable to provide sufficient tumor tissue for analysis. 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. Subjects who are deemed unable to comply with the study requirements or complete the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intratumor heterogeneity (ITH) | 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 | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical utility of ctDNA in EGFR-mutant NSCLC | Clinical utility of ctDNA in dissecting ITH, and its relationship with clinical features and clinical outcomes in EGFR-mutant NSCLC | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EGFR mutation