UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044022 |
|---|---|
| Receipt number | R000050270 |
| Scientific Title | Prospective research for biomarkers for early detection of immune-related adverse events attributed to immune checkpoint inhibitors |
| Date of disclosure of the study information | 2021/04/23 |
| Last modified on | 2024/05/06 23:13:18 |
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Basic information
Public title
Research for early detection of adverse events of immune checkpoint inhibitors
Acronym
Research for early detection of adverse events of immune checkpoint inhibitors
Scientific Title
Prospective research for biomarkers for early detection of immune-related adverse events attributed to immune checkpoint inhibitors
Scientific Title:Acronym
Research for irAE biomarkers
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Research for biomarkers for early detection of immune-related adverse events attributed to immune checkpoint inhibitors
Basic objectives2
Others
Basic objectives -Others
Monitoring for autoimmune regulators as an indicator of side effects
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood concentrations of immunity regulators
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients starting cancer chemotherapy with immune checkpoint inhibitors
Key exclusion criteria
Doctor has determined who are not suitable for research
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Maiko |
| Middle name | |
| Last name | Machida |
Organization
Hokkaido University of Science
Division name
Pharmaceutical Sciences
Zip code
0068585
Address
15-4-1 Maeda 7-jo,Teineku,Sapporo, Japan
TEL
011-676-8652
machida-m@hus.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Machida |
Organization
Hokkaido University of Science
Division name
Pharmaceutical Sciences
Zip code
0068585
Address
15-4-1 Maeda 7-jo,Teineku,Sapporo, Japan
TEL
011-676-8652
Homepage URL
machida-m@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science Faculty of Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University of Science Faculty of Pharmaceutical Sciences
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
Hokkaido University of Science
Address
15-4-1 Maeda 7-jo,Teineku,Sapporo, Japan
Tel
011-688-2241
kenkyu@hus.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
JCHO札幌北辰病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 23 | Day |
Related information
URL releasing protocol
https://drive.google.com/file/d/1tPV7WXqQeUdDVCfe8iH_iWsDt0APd_NQ/view?usp=share_link
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
| Delay expected |
Results Delay Reason
The target number of cases has not been reached and the study period has been extended to continue accepting entries.
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
| 2019 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood concentrations of cytokines were fluctuated attributed to ones irAE. Patients entry progress, but delayed because of Covid-19 pandemic.
Management information
Registered date
| 2021 | Year | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050270
