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

NCT05997719 | Recruiting

• 1 other identifier: B2023-287-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-small Cell Lung Cancer

Keywords

EGFR mutation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical utility of ctDNA in EGFR-mutant NSCLC

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Histologically or cytologically confirmed EGFR-mutant NSCLC

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guanzhou, 510060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tissue, blood

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Shen Zhao, MD.

CONTACT

86 20 87343366; zhaoshen@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Medical Oncology Department

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 18, 2023
• Study Start: August 10, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

CN (1)