UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051336 |
|---|---|
| Receipt number | R000058565 |
| Scientific Title | Immune-related pancreatitis in patients with advanced cancer treated with immune-checkpoint inhibitors. |
| Date of disclosure of the study information | 2023/06/13 |
| Last modified on | 2023/12/13 16:12:49 |
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Basic information
Public title
Immune-related pancreatitis in patients with advanced cancer treated with immune-checkpoint inhibitors.
Acronym
Immune-related pancreatitis
Scientific Title
Immune-related pancreatitis in patients with advanced cancer treated with immune-checkpoint inhibitors.
Scientific Title:Acronym
Immune-related pancreatitis
Region
| Japan |
Condition
Condition
Immune-related pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the current status of immune-related pancreatitis
Basic objectives2
Others
Basic objectives -Others
Reveal the features of image findings of immune-related pancreatitis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To clarify the current status of immune-related pancreatitis
Key secondary outcomes
Reveal the features of image findings of immune-related pancreatitis.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patiens who treated by immune checkpoint inhibitors.
Key exclusion criteria
Patients who have no clinical data
Target sample size
843
Research contact person
Name of lead principal investigator
| 1st name | Yasuki |
| Middle name | |
| Last name | Hori |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Gastroenterology and Metabolism
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
+81528538211
yhori@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yasuki |
| Middle name | |
| Last name | Hori |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Gastroenterology and Metabolism
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
+81528538211
Homepage URL
yhori@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Nagoya City University Graduate School of Medical Sciences
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel
+81528538211
yhori@med.nagoya-cu.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
| 2023 | Year | 06 | Month | 13 | 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
| 2015 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Reveal the current status of immune-related pancreatitis.
Management information
Registered date
| 2023 | Year | 06 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058565
| Research Plan | |
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| 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 |
