UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031806 |
|---|---|
| Receipt number | R000036311 |
| Scientific Title | Analysis of immune-related adverse event by immune checkpoint inhibitor |
| Date of disclosure of the study information | 2018/03/20 |
| Last modified on | 2018/03/20 04:32:06 |
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Basic information
Public title
Analysis of immune-related adverse event by immune checkpoint inhibitor
Acronym
Analysis of irAE
Scientific Title
Analysis of immune-related adverse event by immune checkpoint inhibitor
Scientific Title:Acronym
Analysis of irAE
Region
| Japan |
Condition
Condition
patients treated by immune checkpoint inhibitor
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analysis of irAE
Basic objectives2
Others
Basic objectives -Others
the diagnosis and therapy for irAE
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the prevalence of the gastrointestinal and hepatological irAE
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 treated by immune checkpoint inhibitor in Chiba University hospital
Key exclusion criteria
Patients who are judged as being ina ppropriate for this study by their medic al doctor
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba University Hospital
Division name
Department of medical oncology
Zip code
Address
1-8-1 Inohana, Chuo-Ku, Chiba city
TEL
043-222-7171
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba University Hospital
Division name
Department of medical oncology
Zip code
Address
1-8-1 Inohana, Chuo-Ku, Chiba city
TEL
043-222-7171
Homepage URL
araim-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2018 | Year | 03 | Month | 20 | 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
| 2018 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, 1-4 are assessed.
1.Patient's background
2.Patient's complaint
3.Physical examination and endoscopic findings
4.Laboratory test
Management information
Registered date
| 2018 | Year | 03 | Month | 20 | Day |
Last modified on
| 2018 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036311
