Unique ID issued by UMIN | UMIN000027592 |
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Receipt number | R000031611 |
Scientific Title | Ultra-sensitive detection of the T790M mutation using droplet digital PCR and, efficacy and resistance analysis of EGFR tyrosine kinase inhibitors in pretreatment non-small cell lung cancer patients with EGFR mutation. |
Date of disclosure of the study information | 2017/06/01 |
Last modified on | 2019/12/09 16:24:51 |
Ultra-sensitive detection of the T790M mutation using droplet digital PCR and, efficacy and resistance analysis of EGFR tyrosine kinase inhibitors in pretreatment non-small cell lung cancer patients with EGFR mutation.
Ultra-sensitive detection of the T790M mutation using droplet digital PCR and, efficacy and resistance analysis of EGFR tyrosine kinase inhibitors in pretreatment non-small cell lung cancer patients with EGFR mutation.
Ultra-sensitive detection of the T790M mutation using droplet digital PCR and, efficacy and resistance analysis of EGFR tyrosine kinase inhibitors in pretreatment non-small cell lung cancer patients with EGFR mutation.
Ultra-sensitive detection of the T790M mutation using droplet digital PCR and, efficacy and resistance analysis of EGFR tyrosine kinase inhibitors in pretreatment non-small cell lung cancer patients with EGFR mutation.
Japan |
Non-small cell lung cancer
Hematology and clinical oncology |
Malignancy
YES
Analyse the association between quantitative T790M analysis of pretreatment non-small cell lung cancer with EGFR mutation and efficacy of EGFR tyrosine kinase inhibitor
Perform mutation analysis using next generation sequencer
Compare T790M detection using Cobas V2.0 and degital droplet PCR
Others
Compare quantitative analysis data of T790M using digital droplet PCR and pretreatment data of rebiopsy specimen
Analyse mutation using next generation sequencer of rebiopsy specimen
The association between the quantity of T790M copies and progression free survival of EGFR tyrosine kinase inhibitor treatment
The association between the quantity of T790M copies and response rate or overall survival
The association between efficacy of EGFR tyrosine kinase inhibitor mutations such as CTNNB1 and MET amplification
Compare T790M detection using Cobas V2.0 and degital droplet PCR
Observational
Not applicable |
Not applicable |
Male and Female
[Subject I]
1)Histologically and/or cytologically proven non-small cell lung cancer
2)Locally advanced or metastatic disease
3)EGFR mutation positive (deletion19 or L858R)
4)Start EGFR tyrosine kinase inhibitor treatment as first line therapy from August 2013 to July 2016
5)Have signed an informed consent document
[Subject II]
1)In subject I cases, patients who performed rebiopsy until Descember 2016
2)Have signed an informed consent
none
52
1st name | Tomoya |
Middle name | |
Last name | Kawaguchi |
Osaka City University Graduate School of Medicine
Department of Respiratory Medicine
545-8585
1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
06-6645-3793
kawaguchi.tomoya@med.osaka-cu.ac.jp
1st name | Kenji |
Middle name | |
Last name | Sawa |
Osaka City University Graduate School of Medicine
Department of Respiratory Medicine
545-8585
1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
06-6645-3793
sawa.kenji@med.osaka-cu.ac.jp
Osaka City University
Graduate School of Medicine
Department of Respiratory Medicine
AstraZeneca K.K.
Profit organization
Ethical Committee of Osaka City University Graduate School of Medicine
1-2-7, Asahimachi, Abeno-ku, Osaka
06-6645-3456
irb@med.osaka-cu.ac.jp
NO
2017 | Year | 06 | Month | 01 | Day |
Published
74
Main results already published
2017 | Year | 03 | Month | 13 | Day |
2016 | Year | 10 | Month | 27 | Day |
2017 | Year | 03 | Month | 13 | Day |
2018 | Year | 12 | Month | 31 | Day |
Observational study
2017 | Year | 06 | Month | 01 | Day |
2019 | Year | 12 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031611
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