UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046659 |
|---|---|
| Receipt number | 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 | 2022/10/24 14:54:14 |
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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
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
kait721@keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
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
| 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
No longer 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
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 06 | 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 | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053228
