UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053251 |
|---|---|
| Receipt number | R000060771 |
| Scientific Title | Observational study of chemotherapy for unresectable intrahepatic cholangiocarcinoma |
| Date of disclosure of the study information | 2024/01/10 |
| Last modified on | 2023/12/30 13:32:56 |
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Basic information
Public title
Observational study of chemotherapy for unresectable intrahepatic cholangiocarcinoma
Acronym
Observational study of chemotherapy for unresectable intrahepatic cholangiocarcinoma
Scientific Title
Observational study of chemotherapy for unresectable intrahepatic cholangiocarcinoma
Scientific Title:Acronym
Observational study of chemotherapy for unresectable intrahepatic cholangiocarcinoma
Region
| Japan |
Condition
Condition
ntrahepatic cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluation of optimal treatment options and improvement of prognosis of intrahepatic cholangiocarcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients histologically diagnosed with intrahepatic cholangiocarcinoma.
Patients who plan to start initial systemic chemotherapy after the approval date.
Patients scheduled for cancer gene panel testing
Key exclusion criteria
Patients who are judged to be unsuitable for participation in this study by the principal investigator or the attending physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Inada |
Organization
Kumamoto University
Division name
Department of Gastroenterology and Hepatology, Faculty of Life Sciences
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
0963735150
inada.hiroki@kuh.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Inada |
Organization
Kumamoto University
Division name
Department of Gastroenterology and Hepatology, Faculty of Life Sciences
Zip code
8608556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
0963735150
Homepage URL
inada.hiroki@kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto university
Institute
Department
Personal name
Funding Source
Organization
Kumamoto university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto university
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
Tel
0963735150
inada.hiroki@kuh.kumamoto-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Spatial gene expression analysis
Management information
Registered date
| 2023 | Year | 12 | Month | 30 | Day |
Last modified on
| 2023 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060771
