Unique ID issued by UMIN | UMIN000042408 |
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Receipt number | R000048412 |
Scientific Title | Prospective clinical study of comprehensive genomic profiling for patients with chemotherapy-naive advanced cancer. |
Date of disclosure of the study information | 2020/11/11 |
Last modified on | 2022/12/13 14:55:29 |
Prospective clinical study of comprehensive genomic profiling for patients with chemotherapy-naive advanced cancer.
FIRST-Dx trial
Prospective clinical study of comprehensive genomic profiling for patients with chemotherapy-naive advanced cancer.
FIRST-Dx trial
Japan |
advanced cancer
Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Pneumology | Hematology and clinical oncology | Breast surgery |
Obstetrics and Gynecology | Dermatology |
Malignancy
YES
To evaluate the clinical utility of F1CDx in patients with chemotherapy naive advanced cancer.
Others
Evaluation of clinical utility of F1CDx
Confirmatory
Not applicable
Ratio of cancer patients with actionable genomic alteration
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Age>20 y.o.
ECOG PS 0-1
Pathologically confirmed malignancy
Cancers in GI tracts, biliary tract, pancreas, lung, breast, gynecologic organs, and skin melanoma.
No prior chemotherapy or radiotherapy.
Tissue available for F1CDx
Written informed consent
Inappropriate for trial due to mental disease.
Inappropriate for trial judged by medical doctors.
180
1st name | Manabu |
Middle name | |
Last name | Muto |
Kyoto University Hospital
Department of Clinical Oncology
606-8507
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto-shi
075-751-3111
mmuto@kuhp.kyoto-u.ac.jp
1st name | Junichi |
Middle name | |
Last name | Matsubara |
Kyoto University Hospital
Department of Clinical Oncology
606-8507
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto-shi
075-751-3111
jmatsuba@kuhp.kyoto-u.ac.jp
Kyoto University Hospital
CHUGAI PHARMACEUTICAL CO., LTD.
Profit organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Yoshida-Konoe-cho, Sakyo-ku, Kyoto-shi
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
NO
京都大学医学部附属病院(京都府)、東京大学医学部附属病院(東京都)、東京医科歯科大学医学部附属病院(東京都)、愛知県がんセンター(愛知県)、富山大学附属病院(富山県)、和歌山県立医科大学附属病院(和歌山県)
2020 | Year | 11 | Month | 11 | Day |
Published
https://www.mhlw.go.jp/stf/shingi2/0000205617_00052.html
182
Completed
2020 | Year | 11 | Month | 10 | Day |
2020 | Year | 11 | Month | 30 | Day |
2021 | Year | 05 | Month | 01 | Day |
2022 | Year | 07 | Month | 30 | Day |
2022 | Year | 10 | Month | 31 | Day |
2023 | Year | 01 | Month | 31 | Day |
2023 | Year | 01 | Month | 31 | Day |
This observational study will be conducted as an Advanced Medical Care B
2020 | Year | 11 | Month | 10 | Day |
2022 | Year | 12 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048412
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