UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056902 |
|---|---|
| Receipt number | R000065035 |
| Scientific Title | Biomarkers of Immune-related adverse events for Zoning pathophysiology and Exploring Novel markers |
| Date of disclosure of the study information | 2025/02/03 |
| Last modified on | 2025/02/02 06:51:09 |
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Basic information
Public title
Biomarkers of immune-related adverse events for zoning pathophysiology and exploring novel markers
Acronym
BIZEN-M study
Scientific Title
Biomarkers of Immune-related adverse events for Zoning pathophysiology and Exploring Novel markers
Scientific Title:Acronym
BIZEN-M study
Region
| Japan |
Condition
Condition
Patients with a history of immune checkpoint inhibitor treatment
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify markers predictive of irAE onset, we will perform the MUSCAT Assay (Multiple S-cationized Antigen Beads Array Assay) using plasma from patients treated with immune checkpoint inhibitors
Basic objectives2
Others
Basic objectives -Others
diagnostic ability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will perform the MUSCAT Assay using plasma from patients who developed irAE and those treated with immune checkpoint inhibitors without irAE, and compare the results of anti-cancer antigen antibodies and autoantibodies.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients after immune checkpoint inhibitor administration
Key exclusion criteria
Women who are pregnant or may be pregnant
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357219
iwamuromasaya@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku
TEL
0862357219
Homepage URL
iwamuromasaya@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Masaya Iwamuro
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University IRB
Address
2-5-1 Shikata-cho, Kita-ku
Tel
0862357218
iwamuromasaya@yahoo.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
| 2025 | Year | 02 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Perform the MUSCAT Assay using plasma from patients who developed irAE and those who received immune checkpoint inhibitors without developing irAE, and compare the results of anti-cancer antigen antibodies and autoantibodies
Management information
Registered date
| 2025 | Year | 02 | Month | 02 | Day |
Last modified on
| 2025 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065035
