Prospective observational study for Treatment resistance related gene screening using plasma circulating tumor DNA in the third generation EGFR-TKI Osimertinib therapy

Conditions

Non small cell lung cancer harboring EGFR mutation non-small cell lung cancer, epidermal growth factor receptor

Akihiro Tamiya, Yasuyuki Mizumori, Mitsuo Osuga, Shun‐ichi Isa, Yoshihiko Taniguchi et al. (17 authors)

Cancer Medicine2025-04-011 citations

First report of ELUCIDATOR study: A prospective observational multicenter study on resistance mechanisms in patients with early disease progression during osimertinib.

Yasuyuki Mizumori, Akihiro Tamiya, Mitsuo Osuga, Shun‐ichi Isa, Yoshihiko Taniguchi et al. (17 authors)

Journal of Clinical Oncology2023-06-01

10.1200/jco.2023.41.16_suppl.3032

Prospective observational study for treatment resistance-related gene screening using plasma circulating tumor DNA in the third generation EGFR TKI osimertinib therapy elucidator.

Akihiro Tamiya, Shun‐ichi Isa, Yoshihiko Taniguchi, Masahiko Ando, Shinji Atagi et al. (6 authors)

Journal of Clinical Oncology2019-05-201 citations

10.1200/jco.2019.37.15_suppl.tps3171

Interventions

Blood sampling (every 30ml) x5

Blood sampling

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1) An incidence and ratio of resistance-related gene (mutation) treated with osimertinib with the next generatiom sequencer using the tumour tissue DNA before and after progression of osimertinib if specimen presentation is possible 2) When possible, an incidence and ratio of resistance-related gene (mutation) treated with osimertinib with hypersinsitive next-generation sequence method in ctDNA at three months and 12 months after osimertinib administration 3) To examine how the detection quantity of the resistance-related gene (mutation) treated with osimertinib with hypersinsitive next-generation sequence method in ctDNA at three months and 12 months after osimertinib administration influences condition progress under treatment the osimertinib, if possible 4) To check the sensitive and specific rate of the results (the incidence and rate of the resistance-related gene (mutation)) between using hypersinsitive next-generation sequence method in ctDNA and using the next generatiom sequencer using the tumour tissue DNA 5) To examine background factor and the the resistance-related gene (mutation) of osimertinib treatment in the case of disease rogression at three months and 12 months after osimertinib treatment, and examine the factor which influenced disesase progression exploratorily	—

Measure

Time frame

1) An incidence and ratio of resistance-related gene (mutation) treated with osimertinib with the next generatiom sequencer using the tumour tissue DNA before and after progression of osimertinib if specimen presentation is possible 2) When possible, an incidence and ratio of resistance-related gene (mutation) treated with osimertinib with hypersinsitive next-generation sequence method in ctDNA at three months and 12 months after osimertinib administration 3) To examine how the detection quantity of the resistance-related gene (mutation) treated with osimertinib with hypersinsitive next-generation sequence method in ctDNA at three months and 12 months after osimertinib administration influences condition progress under treatment the osimertinib, if possible 4) To check the sensitive and specific rate of the results (the incidence and rate of the resistance-related gene (mutation)) between using hypersinsitive next-generation sequence method in ctDNA and using the next generatiom sequencer using the tumour tissue DNA 5) To examine background factor and the the resistance-related gene (mutation) of osimertinib treatment in the case of disease rogression at three months and 12 months after osimertinib treatment, and examine the factor which influenced disesase progression exploratorily

—

Contacts

Public ContactShun-ichi Isa

National Hospital Organization Kinki-chuo Chest Medical Center

atamiya-osk@umin.ac.jp+81-72-252-3021

Outcome results

None listed