UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043035 |
|---|---|
| Receipt number | R000049127 |
| Scientific Title | Multicenter retrospective cohort study of the resected pancreatic neuroendocrine tumor |
| Date of disclosure of the study information | 2021/01/17 |
| Last modified on | 2022/03/14 09:07:29 |
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Basic information
Public title
Multicenter study of the resected pancreatic neuroendocrine tumor
Acronym
Japan multicenter resected panNEN cohort study
Scientific Title
Multicenter retrospective cohort study of the resected pancreatic neuroendocrine tumor
Scientific Title:Acronym
Multicenter retrospective cohort study of the resected panNEN
Region
| Japan |
Condition
Condition
pancreatic neuroendocrine tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1.Clarify the lymph node rate and prognosis of the resected small panNEN.
2. Clarify the frequency of the recurrence
after the surgical resection, and identify the recurrent risk factor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lymph node metastases of the panNEN, distant metastasis ratio of less than 2cm with the resection pathological diagnosis excised surgically
Key secondary outcomes
Extraction of recurrent risk factor of all pancreatic neuroendocrine tumors excised surgically
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
1.Pancreatectomy is performed by December2019 from January1996, and a pancreatic neuroendocrine tumor is diagnosed by pathological diagnosis.
2.In a resected specimen, immunostaining of Ki67 is performed.
3.A grade (NET G1,G2,G3, NEC G3,MiNEN) based on WHO2019 classification is possible.
Key exclusion criteria
the case only resection of recurrence lesion (liver metastasis, lymph nodes)
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Hijioka |
Organization
National Cancer Center
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, Japan
TEL
+81-3-3542-2511
shijioka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yayoi |
| Middle name | |
| Last name | Ofuji |
Organization
National Cancer Center
Division name
IRB
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, Japan
TEL
+81-3-3542-2511
Homepage URL
NCC_IRBoffice@ml.res.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japan Pancreatic Society
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
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, Japan
Tel
+81-3-3542-2511
NCC_IRBoffice@ml.res.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
| 2021 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1678
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 01 | Month | 17 | Day |
Last modified on
| 2022 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049127
