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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

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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
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

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
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
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
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

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
Registered date File name

Research case data
Registered date File name


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