Detection Cell Free DNA in Lung Cancer Patients
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
1 other identifier
observational
124
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2016
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 6, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedApril 14, 2016
April 1, 2016
2 years
April 6, 2016
April 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
cf-DNA change from baseline
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.
baseline and every 2 months up to 36 months or first documented progression disease.
Eligibility Criteria
Patients with advanced non-small cell lung cancer (NSCLC),prepare to receive third generation of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) treatment. Patients must harboured with positive EGFR mutation (19 exon deletion, L858R、G719X、L861Q mutation), able to provide periphereal blood and tumor tissue.
You may qualify if:
- pathologically confirmed non small cell lung cancer.
- harboured with positive EGFR mutation (19 exon deletion, L858R、G719X、L861Q mutation)
- reliable patients history data.
You may not qualify if:
- pathologically not confirmed non small cell lung cancer.
- multiple primary cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510030, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li Zhang
Sun Yat-sen University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Profressor
Study Record Dates
First Submitted
April 6, 2016
First Posted
April 14, 2016
Study Start
April 1, 2016
Primary Completion
April 1, 2018
Study Completion
October 1, 2018
Last Updated
April 14, 2016
Record last verified: 2016-04