Prospective observational study for Treatment resistance related gene screening using plasma circulating tumor DNA in the third generation EGFR-TKI Osimertinib therapy
- Conditions
- on small cell lung cancer harboring EGFR mutationnon-small cell lung cancer, epidermal growth factor receptor
- Registration Number
- JPRN-jRCTs031180051
- Lead Sponsor
- Tamiya Akihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
1) Cases in which a definitive diagnosis of non-squamous non-small cell lung cancer has been obtained by histological examination or cytological examination.
2) Cases of inoperable or recurrent non-small cell lung cancer positive for EGFR-TKIs susceptibility gene mutation.
3) Cases in which osimertinib monotherapy is used as the initial treatment.
4) Plasma samples can be submitted.
5) Written consent has been obtained.
1) Cases that the doctor in charge deems inappropriate for this study
2) Cases with experience of allogeneic bone marrow transplantation
3) Cases scheduled for non-leukocyte depletion whole blood transfusion
4) Cases where the consent of the person cannot be obtained
5) Minors under the age of 20
6) Cases of inoperable or recurrent non-small cell lung cancer with negative EGFR-TKIs susceptibility gene mutations (without exon19del, exon21L858R)
7) Cases less than 1 year after postoperative chemotherapy
8) Cases of treatment containing drugs other than osimertinib
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Osimertinib treatment resistance-related genetic mutation's incidence and ratio by the high sensitive next-generation sequence method using ctDNA at before osimertinib treatment and deisease progression
- Secondary Outcome Measures
Name Time Method