UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044830 |
|---|---|
| Receipt number | R000051207 |
| Scientific Title | Retrospective Cohort Study of immune checkpoint inhibitor |
| Date of disclosure of the study information | 2021/07/12 |
| Last modified on | 2022/07/05 09:37:40 |
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Basic information
Public title
Retrospective Cohort Study of immune checkpoint inhibitor
Acronym
Retrospective Cohort Study of immune checkpoint inhibitor
Scientific Title
Retrospective Cohort Study of immune checkpoint inhibitor
Scientific Title:Acronym
Retrospective Cohort Study of immune checkpoint inhibitor
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Surgery in general |
| Hepato-biliary-pancreatic surgery | Breast surgery | Dermatology |
| Oto-rhino-laryngology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify about irAE
Basic objectives2
Others
Basic objectives -Others
time on set of irAE
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A frequency of irAE
Key secondary outcomes
A symptom and time on set of irAE
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 Juntendo hospital from Sep,2014 to Jun,2021
Key exclusion criteria
Patients who are judged as being inappropriate for this study by their medical doctor
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Katou |
Organization
Juntendo University Graduate School of Medicine
Division name
Oncology
Zip code
1138421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL
03-5802-1543
katoshun@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Katou |
Organization
Juntendo University Graduate School of Medicine
Division name
Oncology
Zip code
1138421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL
03-5802-1543
Homepage URL
katoshun@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Juntendo University Hospital department of Clinical Research
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
Tel
03-3813-3111
kenkyu5858@juntendo.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
| 2021 | Year | 07 | Month | 12 | 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
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective Cohort Study
Management information
Registered date
| 2021 | Year | 07 | Month | 12 | Day |
Last modified on
| 2022 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051207
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
