Unique ID issued by UMIN | UMIN000032676 |
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Receipt number | R000037260 |
Scientific Title | Less Invasive Monitoring of Resistance Mutations in Patients with ALK Rearranged Lung Cancer |
Date of disclosure of the study information | 2018/05/22 |
Last modified on | 2022/08/03 10:46:08 |
Less Invasive Monitoring of Resistance Mutations in Patients
with ALK Rearranged Lung Cancer
Liquid Biopsy for ALK rearranged NSCLC
Less Invasive Monitoring of Resistance Mutations in Patients
with ALK Rearranged Lung Cancer
Liquid Biopsy for ALK rearranged NSCLC
Japan |
ALK rearranged NSCLC
Pneumology | Hematology and clinical oncology |
Malignancy
YES
The strategy for early intervention to avoid clinical disease progression is not studied. In this study, we will assess Clinical Feasibility of Serial quantitative monitoring of ALK acquired mutation from plasma using high sensitive and high specific digital PCR method.
Efficacy
Exploratory
To determine duration between clinical PD and emergence of ALK resistant mutations
Concordance of ALK resistant mutations between tissue and plasma using ddPCR
Concordance of ALK resistant mutations between plasma detected by ddPCR and re-biopsy tissue detected by NGS based assay at disease progression
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Age 20 year or older
patients newly diagnosed with ALK+ NSCLC confirmed by tissue biopsy and going to receive ALK-TKIs
patients already diagnosed with ALK+ NSCLC and have received ALK-TKIs
patients who have more than one type of carcinoma
patients who reject to sign the informed consent from
50
1st name | Takaaki |
Middle name | |
Last name | Sasaki |
Asahikawa Medical University
Respiratory Center
078-8510
Midorigaoka-Higashi 2-1-1-1
0166693290
takaaki6@asahikawa-med.ac.jp
1st name | Takaaki |
Middle name | |
Last name | Sasaki |
Asahikawa Medical University
Respiratory Center
0788510
Midorigaoka-Higashi 2-1-1-1
0166-69-3290
takaaki6@asahikawa-med.ac.jp
Asahikawa Medical University
INVESTIGATOR-INITIATED RESEARCH/Pfizer
Outside Japan
Asahikawa Medical University Research Ethics Committee
Midorigaoka-Higashi 2-1-1-1
0166-68-2297
rs-kk.g@asahikawa-med.ac.jp
NO
2018 | Year | 05 | Month | 22 | Day |
Unpublished
Completed
2017 | Year | 12 | Month | 05 | Day |
2017 | Year | 12 | Month | 05 | Day |
2018 | Year | 01 | Month | 05 | Day |
2020 | Year | 11 | Month | 30 | Day |
2020 | Year | 11 | Month | 30 | Day |
2022 | Year | 05 | Month | 01 | Day |
Liquid Biopsy for ALK resistance mutation using ddPCR
2018 | Year | 05 | Month | 22 | Day |
2022 | Year | 08 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037260
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