UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054074 |
|---|---|
| Receipt number | R000061744 |
| Scientific Title | Research study on the treatment patterns of gastrointestinal stromal tumor (GIST) using the claims database |
| Date of disclosure of the study information | 2024/04/05 |
| Last modified on | 2024/04/05 17:05:29 |
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Basic information
Public title
Research study on the treatment patterns of gastrointestinal stromal tumor (GIST) using the claims database
Acronym
Research study on the treatment patterns of GIST
Scientific Title
Research study on the treatment patterns of gastrointestinal stromal tumor (GIST) using the claims database
Scientific Title:Acronym
Research study on the treatment patterns of GIST
Region
| Japan |
Condition
Condition
Gastrointestinal stromal tumor (GIST)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the treatment patterns (e.g., proportion of patients using GIST treatment drugs, TTF, OS) in patients with GIST using the MDV database
Basic objectives2
Others
Basic objectives -Others
To explore the treatment patterns of GIST drug
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To explore the treatment patterns of GIST drug
Key secondary outcomes
Time to treatment failure by GIST drug
Overall survival by GIST drug
Overall survival by the number of GIST drugs used
Exploration of treatment patterns and overall survival after regorafenib
Proportion of adverse events by GIST drug
Proportion of patients who experienced GIST-related surgeries and overall survival with or without GIST-related surgery after starting GIST treatment
Distribution of the number of rechallenges
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
Patients who have a record of definite diagnosis of GIST between July 1, 2013 and March 31, 2023 in the MDV database
Patients who have a record of initial prescription of any GIST drug (Imatinib, Sunitinib, Regorafenib, Pimitespib) and who have a record of definite diagnosis of GIST in the same month
Patients with any record of medical history 60 days or more before the first prescription of any of the GIST drugs described above
Key exclusion criteria
Patients with a record of antitumor drug prescription other than GIST drugs, at least 60 days before the first prescription of GIST drugs
Patients who have a history of radical surgery for GIST, who have received Imatinib as the first prescription, and who have not received any GIST drugs after the completion of Imatinib treatment (adjuvant therapy period)
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | KAZUHIRO |
| Middle name | |
| Last name | OGATA |
Organization
TAIHO PHARMACEUTICAL CO., LTD.
Division name
Medical Affairs Department
Zip code
101-8444
Address
1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo, Japan
TEL
03-3294-4527
th-Medical_Affairs@taiho.co.jp
Public contact
Name of contact person
| 1st name | YUKO |
| Middle name | |
| Last name | HIRANO |
Organization
TAIHO PHARMACEUTICAL CO., LTD.
Division name
Medical Affairs Department
Zip code
101-8444
Address
1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo, Japan
TEL
03-3294-4527
Homepage URL
th-Medical_Affairs@taiho.co.jp
Sponsor or person
Institute
TAIHO PHARMACEUTICAL CO., LTD.
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
Non-Profit Organization MINS IRB
Address
20-9-401, Mita 5-chome, Minato-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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 | 04 | Month | 05 | 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
1847
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
| 2023 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study uses the MDV database. The data are anonymized and no identifiable personal information is included in the database.
Management information
Registered date
| 2024 | Year | 04 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061744
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
