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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000046659 |
Receipt No. | R000053228 |
Scientific Title | A multicenter retrospective study of the efficacy of statins in unresectable or recurrent advanced biliary tract cancer patients. |
Date of disclosure of the study information | 2022/01/17 |
Last modified on | 2022/01/17 |
Basic information | ||
Public title | A multicenter retrospective study of the efficacy of statins in unresectable or recurrent advanced biliary tract cancer patients. | |
Acronym | A multicenter retrospective study of the efficacy of statins in unresectable or recurrent advanced biliary tract cancer patients. | |
Scientific Title | A multicenter retrospective study of the efficacy of statins in unresectable or recurrent advanced biliary tract cancer patients. | |
Scientific Title:Acronym | A multicenter retrospective study of the efficacy of statins in unresectable or recurrent advanced biliary tract cancer patients. | |
Region |
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Condition | |||
Condition | Biliary tract cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | YES |
Objectives | |
Narrative objectives1 | This study is an exploratory study to determine whether statin therapy improves prognosis in patients diagnosed with unresectable advanced recurrent biliary tract cancer. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Overall survival of 1st line paliative chemotherapy (including best supportive care). |
Key secondary outcomes | Overall survival by treatment type in first-line treatment, progression-free survival by treatment type in first-line treatment, and the relationship between survival and the presence of Actionable gene mutations suggested to be associated with statins by cancer genome panel testing. |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Patients diagnosed with unresectable advanced recurrent biliary tract cancer between January 1, 2016 and March 31, 2021.
2) Patients who have received palliative chemotherapy for unresectable advanced recurrent biliary tract cancer. Or, patients who are under the Best Supportive Care (BSC) policy for unresectable advanced recurrent biliary tract cancer and have not received palliative chemotherapy for other carcinomas since diagnosis. 3) Patients with a histological diagnosis of adenocarcinoma or adenosquamous carcinoma, or patients with cytological detection of Adenocarcinoma Class V if the diagnosis is difficult to make by histology. |
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Key exclusion criteria | None | |||
Target sample size | 1500 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Keio University Hospital | ||||||
Division name | Cancer center | ||||||
Zip code | 160-0016 | ||||||
Address | 35, Shinanomachi, Shinjuku-ku, Tokyo | ||||||
TEL | +81333531211 | ||||||
kenro916@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Keio University Hospital | ||||||
Division name | Department of Internal Medicine, Division of Gastroenterology and Hepatology | ||||||
Zip code | 160-0016 | ||||||
Address | 35, Shinanomachi, Shinjuku-ku | ||||||
TEL | +81333531211 | ||||||
Homepage URL | |||||||
kait721@keio.jp |
Sponsor | |
Institute | Keio University Hospital |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Keio University School of Medicine, Ethics committee |
Address | 35, Shinanomachi, Shinjuku-ku, Tokyo |
Tel | 03-3353-1211 |
med-rinri-jimu@adst.keio.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 慶應義塾大学病院(東京都)、国立がん研究センター中央病院(東京都)、がん研究会 有明病院(東京都)、東京慈恵会医科大学附属病院(東京都)、東京慈恵会医科大学附属第三病院(東京都)、東京大学医学部附属病院(東京都)、聖路加国際病院(東京都)、虎の門病院(東京都) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | http://www.keio-med.jp/gastro/index.html |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Other | |
Other related information | Definition of statin and non-statin administration
Patients who have a history of statin prescription at least once from the time of diagnosis of unresectable advanced recurrent biliary tract cancer or the start of related scrutiny to the end of the observation period are defined as "statin-treated group". Patients with unresectable, advanced recurrent biliary tract cancer who have no statin prescriptions in their medical records from the time of diagnosis or start of related examinations until the end of the observation period will be defined as "statin-naive group". |
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Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053228 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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