Unique ID issued by UMIN | UMIN000022063 |
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Receipt number | R000025432 |
Scientific Title | A prospective comparison study of serum maicroRNA panel versus CA19-9 for the diagnosis of pancreatobiliary cancer |
Date of disclosure of the study information | 2016/07/01 |
Last modified on | 2023/10/31 09:13:55 |
A prospective comparison study of serum maicroRNA panel versus CA19-9 for the diagnosis of pancreatobiliary cancer
Serum miRNA panel in the diagnosis of pancreatobiliary cancer
A prospective comparison study of serum maicroRNA panel versus CA19-9 for the diagnosis of pancreatobiliary cancer
Serum miRNA panel in the diagnosis of pancreatobiliary cancer
Japan |
Pancreatobiliary cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To assess the diagnostic value of serum microRNA panel versus CA19-9 in pancreatic and biliary tract cancer, prospectively
Efficacy
Confirmatory
Pragmatic
Phase II
1. In discriminating pancreatobiliary cancer from healthy control, non-inferiority of specificity of serum miRNA panel when comparing the reported CA19-9 data (90-95%) and superiority of sensitivity of serum miRNA panel when comparing CA19-9
2. In discriminating pancreatobiliary cancer from inflammatory pancreatobiliary disease, non-inferiority of sensitivity of serum miRNA panel when comparing the reported CA19-9 data (70-80%) and superiority of specificity of serum miRNA panel when comparing CA19-9
Observational
Not applicable |
Not applicable |
Male and Female
healty subjects, patients with inflammatory pancreatobiliary disease, or patients with pancreatobiliary cancer or gastrointestinal cancer
patients with inflammatory pancreatobiliary disease and malignant disease, patients with anti-cancer treatment for cancer
1280
1st name | Shuichi |
Middle name | |
Last name | Mitsunaga |
National Cancer Center Hospital East
Department of Hepatobiliary and Pancreatic Oncology
277-8577
6-5-1, Kashiwanoha, Chiba
+81-7133-1111
mokojima@east.ncc.go.jp
1st name | Shuichi |
Middle name | |
Last name | Mitsunaga |
National Cancer Center Hospital East
Deparment of Hepatobiliary and Pancreatic Oncology
277-8577
6-5-1, Kashiwanoha, Chiba
+81-7133-1111
smitsuna@east.ncc.go.jp
Japan Agency for Medical Research and Development
Japan Agency for Medical Research and Development
Government offices of other countries
National Cancer Center Institutional Review Board
5-1-1 Tsukiji, Chuo-kuTokyo, 104-0045 Japan
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
NO
2016 | Year | 07 | Month | 01 | Day |
Unpublished
1487
Delay expected |
Main article in progress
No longer recruiting
2016 | Year | 04 | Month | 18 | Day |
2020 | Year | 01 | Month | 22 | Day |
2020 | Year | 02 | Month | 28 | Day |
2020 | Year | 12 | Month | 19 | Day |
2021 | Year | 06 | Month | 19 | Day |
Trial registration was resumed in 2018.
2016 | Year | 04 | Month | 25 | Day |
2023 | Year | 10 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025432
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