UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050162 |
|---|---|
| Receipt number | R000057112 |
| Scientific Title | Risk factors for serious complications associated with the treatment of immune-mediated diseases using a Japanese large-scale database: A large multi-center exploratory study |
| Date of disclosure of the study information | 2023/01/30 |
| Last modified on | 2023/02/06 12:16:39 |
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Basic information
Public title
Risk factors for serious complications associated with the treatment of immune-mediated diseases using a Japanese large-scale database: A large multi-center exploratory study
Acronym
Risk factors for serious complications associated with the treatment of immune-mediated diseases using a Japanese large-scale database: A large multi-center exploratory study
Scientific Title
Risk factors for serious complications associated with the treatment of immune-mediated diseases using a Japanese large-scale database: A large multi-center exploratory study
Scientific Title:Acronym
Risk factors for serious complications associated with the treatment of immune-mediated diseases using a Japanese large-scale database: A large multi-center exploratory study
Region
| Japan |
Condition
Condition
Immune-mediated diseases
Classification by specialty
| Gastroenterology | Clinical immunology | Adult |
| Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluated the occurrence of adverse events such as malignant disease, major adverse cardiovascular events (MACE), serious infections, and venous and pulmonary thrombosis in patients with immune-mediated diseases using the Diagnosis Procedure Combination (DPC) database of the medical fee system collected from national university hospitals in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of malignant disease per 100,000 persons; incidence of malignant disease per 100,000 persons; prevalence of MACE per 100,000 persons; incidence of MACE per 100,000 persons; prevalence of serious infections per 100,000 persons; incidence of serious infections per 100,000 persons; prevalence of venous and pulmonary thrombosis per 100,000 persons; incidence of venous and pulmonary thrombosis per 100,000 persons
Key secondary outcomes
Hazard ratio for malignant disease; hazard ratio for MACE, hazard ratio for severe infection; hazard ratio for venous and pulmonary thrombosis
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We extracted the database records of patients in the database who were diagnosed with immune-mediated diseases between January 2012 and September 2022.
Key exclusion criteria
Patients were excluded from the study if they were diagnosed with malignant disease, MACE, serious infection, or venous or pulmonary thrombosis between April 1, 2008 and December 31, 2011.
Target sample size
200000
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Ochi |
Organization
Institute of Medicine, University of Tsukuba, Hitachi Medical Education and Research Center
Division name
Department of Gastroenterology
Zip code
317-0077
Address
2-1-1 Jonan, Hitachi, Ibaraki Japan
TEL
+81-294-23-1111
masaochiphi@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Masnori |
| Middle name | |
| Last name | Ochi |
Organization
Faculty of Medicine, University of Tsukuba, Hitachi Medical Education and Research Center
Division name
Department of Gastroenterology
Zip code
317-0077
Address
2-1-1 Jonan, Hitachi, Ibaraki Japan
TEL
+81-294-23-1111
Homepage URL
masaochiphi@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576 Japan
Tel
029-853-3900
masaochiphi@md.tsukuba.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
| 2023 | Year | 01 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Centralized Ethics Review Committee: The Database Center, National University Hospitals, The University of Tokyo Hospital
Management information
Registered date
| 2023 | Year | 01 | Month | 27 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057112
| 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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