UMIN-CTR Clinical Trial

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
Email	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
Email	NCC_IRBoffice@ml.res.ncc.go.jp

Sponsor
Institute	National Cancer Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049127