UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026047 |
|---|---|
| Receipt number | R000029936 |
| Scientific Title | Prediction of immune related adverse events by genetic analysis |
| Date of disclosure of the study information | 2017/02/08 |
| Last modified on | 2023/02/13 12:43:04 |
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Basic information
Public title
Prediction of immune related adverse events by genetic analysis
Acronym
Prediction of irAE by genetics
Scientific Title
Prediction of immune related adverse events by genetic analysis
Scientific Title:Acronym
Prediction of irAE by genetics
Region
| Japan |
Condition
Condition
malignant melanoma, lung cancer, renal cancer, Hodgkin lymphoma
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
| Dermatology | Urology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To establish a method to identify immune-related adverse events caused by checkpoint blockade by genetic analysis
Basic objectives2
Others
Basic objectives -Others
Establishing prediction of irAE by genetic analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Immune related adverse event
Key secondary outcomes
efficacy of the treatment
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 receiving immune checkpoint blockade therapy
Key exclusion criteria
Patients under clinical trial
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Nakajima |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
Address
3-9 Fukuura, Kanazawa-Ku, Yokohama
TEL
+81-45-787-2800
sec1nai@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Kirino |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
Address
3-9 Fukuura, Kanazawa-Ku, Yokohama
TEL
+81-45-787-2800
Homepage URL
kirino@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
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
Address
Tel
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
| 2017 | Year | 02 | Month | 08 | 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
| 2017 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Association analysis of irAE and genotyping results
Management information
Registered date
| 2017 | Year | 02 | Month | 08 | Day |
Last modified on
| 2023 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029936
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| Registered date | File name |
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