Frequency of T790M Mutation on Circulating Tumor DNA in EGFR-mutated NSCLC Patients With acquired resistance to irreversible EGFR-TKI :a prospective observational study
- Conditions
- EGFR-mutated Non Small Cell Lung Cancer
- Registration Number
- JPRN-UMIN000024198
- Lead Sponsor
- Yokohama city university
- Brief Summary
iquid biopsy detected EGFR mutations in 63.6% of the patients at diagnosis. Patients with positive EGFR mutations at diagnosis had significantly shorter overall and progression-free survival than patients with negative EGFR mutations. Four of 18 patients (22.2%) who reached progressive disease were positive EGFR T790M mutations. Only two patients were positive for major EGFR mutations at intermediate levels.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1 Patients with pre-treatment of EGFR-TKI 2 Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest X-ray 3 Synchronous double or multiple cancer or metachronous double or multiple cancer 4 Uncontrolled pleural, ascites effusion or cardiac effusion 5 Patients with active co-morbidities including severe conditions. -Uncontrollable angina pectoris, myocardial infarction within 3 months, heart failure -Uncontrolled diabetes mellitus, hypertension -Severe infection -Patients whose participation in the trial is judged to be inappropriate by the attending doctor -Any other patients who are regarded as unsuitable for this trial by the attending doctor
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of T790M Mutation on ctDNA in patients with acquired resistance to irreversible EGFR-TKI
- Secondary Outcome Measures
Name Time Method Evaluation of the relationship between effect of irreversible EGFR-TKI and T790M mutation status