UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055174 |
|---|---|
| Receipt number | R000063028 |
| Scientific Title | Real-world clinical outcomes associated with gene mutation patterns in patients with biliary tract cancer (BTC) in Japan |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/10/27 15:03:00 |
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Basic information
Public title
Real-world clinical outcomes associated with gene mutation patterns in patients with biliary tract cancer (BTC) in Japan
Acronym
Real-world clinical outcomes associated with gene mutation patterns in patients with biliary tract cancer (BTC) in Japan
Scientific Title
Real-world clinical outcomes associated with gene mutation patterns in patients with biliary tract cancer (BTC) in Japan
Scientific Title:Acronym
Real-world clinical outcomes associated with gene mutation patterns in patients with biliary tract cancer (BTC) in Japan
Region
| Japan |
Condition
Condition
Biliary tract cancer (BTC)
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To describe the status of HER2 alterations and MDM2 amplification along with TP53 mutation among BTC subtype-based cohorts
Basic objectives2
Others
Basic objectives -Others
This study is designed to clarify the patient characteristics, drug response, and clinical outcomes by gene mutation and first-line treatment patterns among patients with BTC using the C-CAT database. Additionally, association between mutation patterns identified in the clustering analysis/molecular-interaction pathway analysis and clinical outcomes are investigated.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The following outcomes will be described among subgroups categorized by gene mutation patterns (HER2/MDM2/TP53), first-line treatment types, as well as BTC subtype-based cohorts.
1. HER2 alterations, MDM2 amplification, TP53 mutation
2. First-line treatment types
3. Baseline demographics and clinical characteristics
4. Overall response rate (ORR)
5. Disease control rate (DCR)
6. Time on treatment (ToT)
7. Overall survival (OS)
Key secondary outcomes
The following outcomes will be examined among subgroups categorized by BTC subtype-based cohorts.
1. To describe the OS following the administration of each 1L treatment type by thirty genes with the highest frequency of gene mutations
2. To examine association between co-mutations identified by the clustering analysis and the drug response to 1L treatment (ORR and DCR)
3. To examine association between identify mutations in the gene sets by the molecular-interaction pathway analysis and the drug response to 1L treatment (ORR and DCR)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 18 years and older at registration in the C-CAT database.
2. Patients who have BTC diagnostic information.
3. Patients with a medical record in the C-CAT database.
Key exclusion criteria
None.
Target sample size
4700
Research contact person
Name of lead principal investigator
| 1st name | Takeaki |
| Middle name | |
| Last name | Ishii |
Organization
Nippon Boehringer Ingelheim Co., Ltd
Division name
Oncology Medicine Department. 1, Medical Affairs
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL
03-6683-3935
takeaki.ishii@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Takeaki |
| Middle name | |
| Last name | Ishii |
Organization
Nippon Boehringer Ingelheim Co., Ltd
Division name
Oncology Medicine Department. 1 Medical Affairs
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL
03-6683-3935
Homepage URL
takeaki.ishii@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takahashi Clinic Ethics Committee
Address
Medicalhat 1F, 5-1-31, Iwayakita-machi, Nada-ku, Kobe-shi, Hyogo 657-0846
Tel
078-882-6432
kishimoto.satoshi@neues.co.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 | 10 | Month | 01 | 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
4700
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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 16 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 16 | Day |
Date trial data considered complete
| 2024 | Year | 07 | Month | 16 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 27 | Day |
Other
Other related information
1. A non-interventional/observational, cohort study using existing data (C-CAT database).
2. The C-CAT database enrollment began in June 2019, and this study will use data on the date of data extraction in 2024.
3. The objective of this study is to clarify the patient characteristics with HER2, MDM2, and TP53 alternations along with clinical outcomes among patients with BTC, and furthermore, to identify BTC-related gene mutations to examine the co-mutation patterns and their impact on treatment outcomes.
Management information
Registered date
| 2024 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063028
