UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060126 |
|---|---|
| Receipt number | R000068766 |
| Scientific Title | immune-related adverse events study in Saitama Medical University International Medical Center |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/12/18 22:31:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on immune-related adverse events developing in malignant tumor patients treated with immune checkpoint inhibitors in our hospital
Acronym
A study on immune-related adverse events developing in malignant tumor patients treated with immune checkpoint inhibitors in our hospital
Scientific Title
immune-related adverse events study in Saitama Medical University International Medical Center
Scientific Title:Acronym
SMU-IMC-irAE study
Region
| Japan |
Condition
Condition
immune-related adverse events
Classification by specialty
| Clinical immunology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Immune checkpoint molecules (PD-1, CTLA-4) expressed by T cells function to suppress the activation of T cells themselves, playing a role in stopping the runaway activation of T cells. PD-L1, the ligand for PD-1, is also one of the immune checkpoint molecules. When a target cell (such as a cancer cell) expresses PD-L1, it binds to PD-1 on the T cell, thereby suppressing T cell activation (attack). Immune checkpoint inhibitors (ICIs), which are antibody preparations targeting these immune checkpoints, activate T cells. Consequently, ICIs have become used in the treatment of malignant tumors. However, ICIs can sometimes cause autoimmune disease-like side effects, termed immune-related adverse events (irAEs), which have become a significant concern. The objective of this study is to clarify the characteristics of irAE, which is expected to contribute to future countermeasures against irAE.
Basic objectives2
Others
Basic objectives -Others
This study is an investigative study to clarify the characteristics of irAE at our hospital.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Age, gender, type of malignant tumor and duration of disease, type of ICI used for treatment, presence or absence of irAE, type of irAE, time to onset of irAE, confirmation of immune abnormalities such as autoantibodies, details of irAE treatment, continuation of ICI after irAE occurrence
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 with malignant tumors who received treatment with immune checkpoint inhibitors
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yasuto |
| Middle name | |
| Last name | Araki |
Organization
Saitama Medical University International Medical Center
Division name
Department of Hospital Medicine
Zip code
350-1298
Address
1397-1 Yamane, Hidaka-shi, Saitama
TEL
042-984-4111
arakiya@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasuto |
| Middle name | |
| Last name | Araki |
Organization
Saitama Medical University International Medical Center
Division name
Department of Hospital Medicine
Zip code
350-1298
Address
1397-1 Yamane, Hidaka-shi, Saitama
TEL
042-984-4111
Homepage URL
arakiya@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
Saitama Medical University International Medical Center
Address
1397-1 Yamane, Hidaka-shi, Saitama
Tel
042-984-4111
arakiya@saitama-med.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
| 2026 | Year | 04 | 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
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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collect information including age, gender, type of malignant tumor and duration of disease, type of immune checkpoint inhibitor (ICI) used for treatment, presence or absence of irAE, type of irAE, time to onset of irAE, confirmation of immune abnormalities such as autoantibodies, details of irAE treatment, and whether ICI was continued after irAE occurrence.
Management information
Registered date
| 2025 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068766
