UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	Biliary tract cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology
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
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Institution consideration
Blocking
Concealment

Intervention
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Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
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.
Key exclusion criteria	None
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Kenro Middle name Last name Hirata
Organization	Keio University Hospital
Division name	Cancer center
Zip code	160-0016
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	+81333531211
Email	kenro916@gmail.com

Public contact
Name of contact person	1st name Kai Middle name Last name Tsugaru
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
Email	kait721@keio.jp

Sponsor
Institute	Keio University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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Other related organizations
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IRB Contact (For public release)
Organization	Keio University School of Medicine, Ethics committee
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
Tel	03-3353-1211
Email	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	2022 Year 01 Month 17 Day

Related information
URL releasing protocol	http://www.keio-med.jp/gastro/index.html
Publication of results	Unpublished

Result
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Results
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Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2021 Year 08 Month 12 Day
Date of IRB	2021 Year 10 Month 01 Day
Anticipated trial start date	2021 Year 12 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 05 Month 31 Day
Date trial data considered complete	2022 Year 06 Month 30 Day
Date analysis concluded	2022 Year 09 Month 30 Day

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".

Management information
Registered date	2022 Year 01 Month 17 Day
Last modified on	2022 Year 01 Month 17 Day

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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