Detection Cell Free DNA in Lung Cancer Patients
- Conditions
- Non-small Cell Lung Cancer
- Registration Number
- NCT02738593
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
third generation of EGFR-TKIs is the newest target therapy for NSCLC. However, we did not known the specific mechanisms for those non-responders and patients grow resistance.Next generation sequencing is current the most sensitive and specific method to exam gene mutation, diversion etc.
By consistently detect the cf-DNA, we could possibly find out the mechanisms of response and resistance.
- Detailed Description
Study backgroud: third generation of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) is the newest target therapy for non small cell lung cancer (NSCLC). Two major study published in NEJM show that the overall response rate is about 60%-70%, with a progression free survival about 10 months. However, we did not known the specific mechanisms for those non-responders and patients grow resistance.
Next generation sequencing is current the most sensitive and specific method to exam gene mutation, diversion etc. By consistently detect the cf-DNA, we could possibly find out the mechanisms of response and resistance.
Eligible patients received 3rd generation EGFR-TKIs (AZD9291 and AVITINIB) were enrolled into this study. Tumor tissue sample within 6 months, and 10ml periphereal blood samples were collected at baseline. After treatment initiation, 10ml periphereal blood would be collected at every image testing time point until disease progression. Blood samples will be draw using EDTA tube and centerfuged within 2 hours and store in -80 refrigerator.
NGS testing will cover target genes of NSCLC.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 124
- pathologically confirmed non small cell lung cancer.
- harboured with positive EGFR mutation (19 exon deletion, L858R、G719X、L861Q mutation)
- reliable patients history data.
- pathologically not confirmed non small cell lung cancer.
- multiple primary cancer.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cf-DNA change from baseline baseline and every 2 months up to 36 months or first documented progression disease. Using next generation sequencing (NGS) method to detect circulating free DNA (cf-DNA) in patients receive third generation EGFR-TKI, periphereal blood sample were collected at baseline and every 2 months to disease progression.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Sun Yat-Sen University Cancer Center
🇨🇳GuangZhou, Guangdong, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China