UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056597 |
|---|---|
| Receipt number | R000064681 |
| Scientific Title | A Multimodal AI-Based System for Predicting the Grade of Pancreatic Neuroendocrine Tumors |
| Date of disclosure of the study information | 2024/12/28 |
| Last modified on | 2025/06/29 10:22:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Multimodal AI-Based System for Predicting the Grade of Pancreatic Neuroendocrine Tumors
Acronym
A Multimodal AI-Based System for Predicting the Grade of Pancreatic Neuroendocrine Tumors
Scientific Title
A Multimodal AI-Based System for Predicting the Grade of Pancreatic Neuroendocrine Tumors
Scientific Title:Acronym
A Multimodal AI-Based System for Predicting the Grade of Pancreatic Neuroendocrine Tumors
Region
| Japan |
Condition
Condition
Pancreatic Neuroendocrine Tumors
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop a multimodal AI-based system for predicting the grade of pancreatic neuroendocrine tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance rate between the prediction model and the Grade of resected specimens.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible cases for registration must meet all of the following criteria
1. Preoperative contrast-enhanced CT and EUS examinations were performed, followed by definitive surgical resection between January 1996 and December 2024, with a final pathological diagnosis of pancreatic neuroendocrine tumor (including NEC G3 and MiNEN) based on the resected specimen. Surgical techniques are not restricted.
2. Ki-67 imuunostaining was performed on the resected specimen and the Ki-67 labeling index is available.
3. Malignancy grading (NET G1, G2, G3, NEC) based on the WHO 2019 classification is feasible using the resected specimen.
Key exclusion criteria
Cases meeting the following criteria will be excluded:
1. Surgical resection of recurrence lesions only (e.g., liver metastases, lymph nodes).
2. Surgical resection of metastatic lesions solely for the purpose of mass reduction or alleviation of hormone-producing symptoms.
3. Cases that are difficult to differentiate from conventional pancreatic cancer in pathological diagnosis.
4. MiNEN.
5. Cases deemed unsuitable for this study by the principal investigator or co-investigators.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Hijioka |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
shijioka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Yamashige |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
dyamashi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding
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
National Cancer Center Hospital
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
irst@ncc.go.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
| 2024 | Year | 12 | Month | 28 | 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
| 2024 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective, multi-center, study.
The following contents will be observed retrospectively.
Patient characteristics (sex, age at the time of surgery)
Presence or absence of hormone-producing symptoms (functional NET)
Presence or absence of hereditary tumors (e.g., MEN1, VHL)
Tumor location, size, and imaging information
Clinical stage
Presence and type of preoperative treatments
Surgical details (date of surgery, surgical procedure)
Detailed pathological diagnosis of pancreatic NET (e.g., progression based on pancreatic cancer guidelines, presence of vascular invasion, lymph node metastasis)
Presence or absence of recurrence
Recurrence patterns
Overall survival (OS)
Recurrence-free survival (RFS)
Management information
Registered date
| 2024 | Year | 12 | Month | 28 | Day |
Last modified on
| 2025 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064681
