Unique ID issued by UMIN | UMIN000029315 |
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Receipt number | R000033509 |
Scientific Title | Research on Liquid Biopsy in Patients with Gastrointestinal and Abdominal Malignancies, Including Colorectal Cancer |
Date of disclosure of the study information | 2017/12/01 |
Last modified on | 2021/10/13 11:26:26 |
Research on Liquid Biopsy in Patients with Gastrointestinal and Abdominal Malignancies, Including Colorectal Cancer
GOZILA Study
Research on Liquid Biopsy in Patients with Gastrointestinal and Abdominal Malignancies, Including Colorectal Cancer
GOZILA Study
Japan |
Unresectable advanced or reccurrent gastrointestinal malignancies
Gastroenterology | Hematology and clinical oncology |
Malignancy
YES
The objectives of this study are to analyze circulating tumor DNA to identify cancer-associated genomic alterations using blood samples collected from patients with unresectable advanced or reccurrent gastrointestinal malignancies
Others
To investigate the relationships between cancer-associated genomic alterations in blood samples and clinicopathological and molecular biological profiles, clinical course, and cancer-associated genomic alterations in cancer tissue.
Prevalence of genomic alterations in 74 cancer-associated genes detected by Guardant360
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. Must be aged 20 years or older at the time of consent;
2. Solid malignancies diagnosed by histopathological, cytological, or other examinations as the following:
i.Colorectal cancer ii.Gastric cancer iii.Esophageal cancer iv.Hepatocellular carcinoma v.Biliary cancer vi.Pancreatic cancer vii.Small intestine cancer viii.Appendix cancer ix.Anal canal cancer x.Neuroendocrine carcinoma of intestinal origin xi.Gastrointestinal stromal tumors xii.Breast cancer xiii.Head and Neck Cancer xiv.Other solid malignancies with specific genetic alterations
3. Must have an unresectable advanced/recurrent malignancy
4. Must have a life expectancy of at least 12 weeks;
5. Must have given written consent;
6. Must have disease progression confirmed on imaging or clinical PD suspected by the study doctor during drug therapy and must have not started subsequent therapy. However, patients with gastric, esophageal or colorectal cancer who has not received any chemotherapy, and patients with breast cancer who has not received any chemotherapy and has specific genetic alterations are eligible. It also targets pancreatic cancer patients under the age of 60 who have not been treated before chemotherapy.
1. Lymphoid malignancy
2. Have a history of bone marrow or organ transplantation;
3. Are pregnant; or
4. Are judged by the study doctor to be ineligible for the study for any other reason.
7000
1st name | Yoshino |
Middle name | |
Last name | Takayuki |
National Cancer Center Hospital East
Department of Gastroenterology and Gastrointestinal Oncology
277-8577
6-5-1, Kashiwanoha, Kashiwa, Chiba
04-7133-111
tyoshino@east.ncc.go.jp
1st name | Yoshiaki |
Middle name | |
Last name | Nakamura |
National Cancer Center Hospital East
Department of Gastroenterology and Gastrointestinal Oncology
277-8577
6-5-1, Kashiwanoha, Kashiwa, Chiba
04-7133-111
yoshinak@east.ncc.go.jp
National Cancer Center Hospital East
AMED
Japanese Governmental office
Graduate School of Frontier Sciences, University of Tokyo
Guardant Health
Ono Pharmaceutical
Taiho Pharmaceutical
Takeda Pharmaceutical
Daiichi Sankyo Company
Merus N.V.
Hokkaido University Hospital
National Cancer Center Institutional Review Board
5-1-1, tsukiji, tyuo-ku, tokyo
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
NO
http://www.scrum-japan.ncc.go.jp/monstar_screen/institutions/index.html
2017 | Year | 12 | Month | 01 | Day |
Unpublished
Open public recruiting
2017 | Year | 09 | Month | 26 | Day |
2017 | Year | 10 | Month | 31 | Day |
2017 | Year | 10 | Month | 26 | Day |
2027 | Year | 03 | Month | 31 | Day |
Study Design: Observational study
Target population:the patients who meet the selection criteria until March 31 2024 from research permit date
2017 | Year | 09 | Month | 27 | Day |
2021 | Year | 10 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033509
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