UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042923 |
|---|---|
| Receipt number | R000048808 |
| Scientific Title | Nation-wide multicenter registry for Myocardial Damage associated with immune checkpoint inhibitor administration |
| Date of disclosure of the study information | 2021/01/10 |
| Last modified on | 2023/03/16 10:27:46 |
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Basic information
Public title
Nation-wide multicenter registry for Myocardial Damage associated with immune checkpoint inhibitor administration
Acronym
MD-ICI
Scientific Title
Nation-wide multicenter registry for Myocardial Damage associated with immune checkpoint inhibitor administration
Scientific Title:Acronym
MD-ICI
Region
| Japan |
Condition
Condition
Myocardial Damage associated with immune checkpoint inhibitor administration
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Case registration
Basic objectives2
Others
Basic objectives -Others
Exploratory research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incident rate, onset time, and risk factors
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who develop myocardial damage after ICI treatment
Key exclusion criteria
-
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Tamura |
Organization
International University of Health and Welfare
Division name
Cardiovascular internal medicine
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku Tokyo
TEL
0334518175
u1@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | asuka |
| Middle name | |
| Last name | furukawa |
Organization
International University of Health and Welfare, Mita Hospital
Division name
Cardiovascular internal medicine
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku Tokyo
TEL
0334518121
Homepage URL
asukaf0326@gmail.com
Sponsor or person
Institute
AMED
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare, Mita Hospital
Address
1-4-3 Mita, Minato-ku Tokyo
Tel
0334518121
soumu-mita.hosp@iuhw.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
| 2021 | 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
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Information on myocarditis, background, history of anticancer drug, laboratory findings, treatment details, toxicity events
Management information
Registered date
| 2021 | Year | 01 | Month | 06 | Day |
Last modified on
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048808
