Exploring Cancer Evolution, Prognostic and Predictive Biomarkers in EGFR-mutant NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To investigate genomic architecture, cancer evolution and their relationship with clinical outcomes in EGFR-mutant NSCLC.
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.
Primary outcome measures
- Intratumor heterogeneity (ITH) [Time frame: 5 years]
Secondary outcome measures (1)
- Clinical utility of ctDNA in EGFR-mutant NSCLC [Time frame: 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guanzhou
Identifiers
NCT: NCT05997719 · B2023-287-01