UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060653 |
|---|---|
| Receipt number | R000069369 |
| Scientific Title | A Japanese nationwide multi-institutional retrospective survey of the treatments for neuroendocrine liver metastases (J-NELM study) |
| Date of disclosure of the study information | 2026/02/12 |
| Last modified on | 2026/02/12 12:03:05 |
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Basic information
Public title
A Japanese nationwide multi-institutional retrospective survey of the treatments for neuroendocrine liver metastases
(J-NELM study)
Acronym
J-NELM study
Scientific Title
A Japanese nationwide multi-institutional retrospective survey of the treatments for neuroendocrine liver metastases
(J-NELM study)
Scientific Title:Acronym
J-NELM study
Region
| Japan |
Condition
Condition
neuroendocrine liver metastasis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is (1) to examine the effect of first line therapy on progonsis of neuroendocrine liver metastasis (NELM), and (2) to clarify prognostic factors for NELM.
Basic objectives2
Others
Basic objectives -Others
Examination between Ki-67 index of NELM and survival outcomes
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Recurrence/progresion-free survival, Prognotic factors
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who received first-line therapy for neuroendocrine liver metastatsis between Jan 1 2012 through March 31 2025.
Key exclusion criteria
Patients who decline the registration of data.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Aoki |
Organization
Dokkyo Medical University Hospital
Division name
Department of Heapto-Biliary-Pancreatic Surgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282861111
aoki-2su@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Aoki |
Organization
Dokkyo Medical University Hospital
Division name
Department of Heapto-Biliary-Pancreatic Surgery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282861111
Homepage URL
aoki-2su@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Taku Aoki
Funding Source
Organization
Japan Neuroendocrine Tumor Society (JNETS)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University Hospital
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
Tel
0282861111
aoki-2su@dokkyomed.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
Tochigi
Institutions
Institutions
獨協医科大学病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | 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
500
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2030 | Year | 12 | Month | 31 | Day |
Other
Other related information
Multi-institutional cohort study including 26 institutions.
Management information
Registered date
| 2026 | Year | 02 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069369
