Unique ID issued by UMIN | UMIN000036871 |
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Receipt number | R000042014 |
Scientific Title | Lung Cancer Genomic Screening Project for Individualized Medicine in Asia |
Date of disclosure of the study information | 2019/06/01 |
Last modified on | 2022/05/30 09:20:18 |
Lung Cancer Genomic Screening Project for Individualized Medicine in Asia
LC-SCRUM-Asia
Lung Cancer Genomic Screening Project for Individualized Medicine in Asia
LC-SCRUM-Asia
Japan |
Non-small cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
YES
To characterize the clinicopathological and molecular biological features of lung cancer with specific gene alterations identified in the genomic screening
Others
To promote the development of novel target therapies and diagnostics through genome screening.
To characterize the clinicopathological and molecular biological features of lung cancer with genetic alterations identified in the genomic screening
Observational
16 | years-old | <= |
Not applicable |
Male and Female
1) Patients aged 16 years or older
2) Patients with pathologically (histology or cytology) confirmed non-small cell lung cancer
3) Patients with cancer of clinical stage II or higher, or postoperative recurrence
4) Patients who have not received any drug treatments or have a history of two or less drug regimens for lung cancer (Patients with a history of three or more drug regimens are not eligible. However, preoperative/postoperative adjuvant chemotherapy is not included in the calculation of the number of regimens)
5) Eastern Cooperative Oncology Group performance status (PS) of 0 or 1
6) Patients who meet the following criteria for major organ function (assessed by a test performed within 2 weeks prior to study enrollment):
i) Neutrophil count : >=1500/mm3
ii) Hemoglobin : >=8.0 g/dl
iii) Platelet count : >=7.5 x 104/mm3
iv) AST, ALT : <=ULN (upper limit of normal) x 2.5 (x 5 in patients with liver metastasis)
v) Total bilirubin : <=ULN x 1.5
7) Patients without serious complications (e.g., interstitial pneumonitis, poorly controlled diabetes mellitus, cardiac disease, infection, etc.)
8) Patients who are expected to live for at least 3 months from the date of study enrollment
9) Patients who are able to submit samples that can be used for genetic analyses. The samples must be ones collected before the initial drug treatment
10) Patients who wish to enroll in genotype-directed clinical trials if the target gene alterations are identified in this study
11) Patients who have provided written consent to enroll in this study
none
2500
1st name | Koichi |
Middle name | |
Last name | Goto |
National Cancer Center Hospital East
Department of Thoracic Oncology
277-8577
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
04-7133-1111
kgoto@east.ncc.go.jp
1st name | Matsumoto |
Middle name | |
Last name | Shingo |
National Cancer Center Hospital East
Department of Thoracic Oncology
277-8577
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
04-7133-1111
shmatsum@east.ncc.go.jp
National Cancer Center Hospital East
Ministry of Health, Labour and Welfare
Japanese Governmental office
National Cancer Center Hospital East
6-5-1, Kashiwanoha, Kashiwa, Chiba
04-7133-111
irst@ml.res.ncc.go.jp
NO
2019 | Year | 06 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2019 | Year | 03 | Month | 12 | Day |
2019 | Year | 03 | Month | 28 | Day |
2019 | Year | 06 | Month | 10 | Day |
2041 | Year | 03 | Month | 31 | Day |
This study is a prospective observational study.
2019 | Year | 05 | Month | 28 | Day |
2022 | Year | 05 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042014
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