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Trial Title:
Exploring Cancer Evolution, Prognostic and Predictive Biomarkers in EGFR-mutant NSCLC
NCT ID:
NCT05997719
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
EGFR mutation
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
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.
Criteria for eligibility:
Study pop:
Histologically or cytologically confirmed EGFR-mutant NSCLC
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guanzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Zhang, MD.
Phone:
86 20 87343366
Email:
zhangli@sysucc.org.cn
Start date:
August 10, 2023
Completion date:
December 31, 2030
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05997719
