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Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis
Conditions
EGFR Mutation Positive Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: EGFR TKIs (gefitinib, erlotinib, afatinib, et al)
Type: Drug
Overall Status
Recruiting
Summary
To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:
- 1. Histologically confirmed NSCLC 2. Aged of or older than 20 years 3. ECOG performance status 0-2 4. Adequate hematological, renal, hepatic function 5. Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6. Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI) 7. At least more than one measurable disease 8. Informed consent
Exclusion Criteria:
- 1. Active infection 2. Active bleeding
- 1. Histologically confirmed NSCLC 2. Aged of or older than 20 years 3. ECOG performance status 0-2 4. Adequate hematological, renal, hepatic function 5. Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6. Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI) 7. At least more than one measurable disease 8. Informed consent
Exclusion Criteria:
- 1. Active infection 2. Active bleeding
Location
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Myung-Ju Ahn, M.D., Ph.D. - silkahn@skku.edu
Start Date
June 2012
Completion Date
May 2015
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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