UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060634 |
|---|---|
| Receipt number | R000069351 |
| Scientific Title | Effects of immune checkpoint inhibitor-related pancreatic injury (ICI-PI) on pancreatic endocrine and exocrine function and pancreatic morphological changes: a multicenter retrospective observational study |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/02/09 23:35:17 |
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Basic information
Public title
Effects of immune checkpoint inhibitor-related pancreatic injury on pancreatic function: a multicenter retrospective observational study
Acronym
ICI-PI on pancreatic function study
Scientific Title
Effects of immune checkpoint inhibitor-related pancreatic injury (ICI-PI) on pancreatic endocrine and exocrine function and pancreatic morphological changes: a multicenter retrospective observational study
Scientific Title:Acronym
ICI-PI on pancreatic function study
Region
| Japan |
Condition
Condition
Immune checkpoint inhibitor-related pancreatic injury (ICI-PI)
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate the incidence of pancreatic atrophy and new-onset diabetes or worsening of glucose tolerance in patients with immune checkpoint inhibitor-related pancreatic injury (ICI-PI).
Basic objectives2
Others
Basic objectives -Others
To describe the longitudinal course of pancreatic morphological changes and pancreatic endocrine and exocrine function after ICI-PI, and to exploratorily evaluate associations with the development of pancreatic calcification, pancreatic exocrine insufficiency, and survival outcomes (PFS and OS).
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of pancreatic atrophy and new-onset diabetes or worsening of glucose tolerance in patients with immune checkpoint inhibitor-related pancreatic injury (ICI-PI)
Key secondary outcomes
Incidence of pancreatic calcification and pancreatic exocrine insufficiency
Progression-free survival (PFS)
Overall survival (OS)
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
| 128 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Case-enriched cohort (multicenter; patients with ICI-PI)]
1. Patients who developed immune checkpoint inhibitor-related pancreatic injury (ICI-PI) after receiving immune checkpoint inhibitors (ICIs) at participating institutions, including collaborating centers, between September 2014 and April 2019
2. Patients whose clinical course and outcome data are available from medical records
3. Patients aged 18 years or older at the start of ICI treatment
[Comparative cohort (single-center consecutive cohort; source population for comparative analyses)]
1. Consecutive patients who received immune checkpoint inhibitors (ICIs) at Kobe University Hospital between September 2014 and April 2019
2. Patients whose clinical course and outcome data are available from medical records
3. Patients aged 18 years or older at the start of ICI treatment
Key exclusion criteria
Patients who declined participation via the opt-out process following public disclosure of the study information
Target sample size
274
Research contact person
Name of lead principal investigator
| 1st name | Arata |
| Middle name | |
| Last name | Sakai |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5111
asakai@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Okamoto |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5111
Homepage URL
kookamot@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Kobe University Hospital, Clinical and translational research center.
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
078-382-6669
kansatsu@med.kobe-u.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
| 2026 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study using medical record data, with no treatment interventions or additional procedures. No additional burden is imposed on participants, and the study is conducted with approval from the institutional review boards of the participating institutions using an opt-out consent process.
Management information
Registered date
| 2026 | Year | 02 | Month | 09 | Day |
Last modified on
| 2026 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069351
