Detection Cell Free DNA in Lung Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02738593|
Recruitment Status : Unknown
Verified April 2016 by Li Zhang, Sun Yat-sen University.
Recruitment status was: Active, not recruiting
First Posted : April 14, 2016
Last Update Posted : April 14, 2016
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.
|Condition or disease|
|Non-small Cell Lung Cancer|
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.
|Study Type :||Observational|
|Estimated Enrollment :||124 participants|
|Official Title:||Using Next Generation Sequencing (NGS) Method to Detect Circulating Free DNA (Cf-DNA) and Explore the Resistance and Prognosic Mechanism of Third Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine-kinase Inhibitor (TKI) in Advanced Non-small Cell Lung Cancer (NSCLC) Patients: a Single Center Study|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||October 2018|
- cf-DNA change from baseline [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
periphereal blood 10ml,centrifuge:4℃、2400g、10min,extracted plasma and stored in -80° refrigerator.
fresh tumor tissue sample,store in freezing medium within 2 hours. FFPE tumor tissue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738593
|Sun Yat-Sen University Cancer Center|
|GuangZhou, Guangdong, China, 510030|
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||Li Zhang||Sun Yat-sen University|