UMIN-CTR Clinical Trial

Basic information
Public title	Nationwide registry for patients with pancreatic, gastroenteral, bronchopulmonary, and thymic neuroendocrine tumors in Japan
Acronym	Nationwide NET registry
Scientific Title	Nationwide registry for patients with pancreatic, gastroenteral, bronchopulmonary, and thymic neuroendocrine tumors in Japan
Scientific Title:Acronym	Nationwide NET registry
Region	Japan

Condition
Condition	Pancreatic, gastroenteral, bronchopulmonary, and thymic neuroendocrine tumors
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Endocrinology and Metabolism Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Endocrine surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To establish nationwide registry and database for clinical study/clinical trial for patients with pancreatic, gastroenteral, bronchopulmonary, and thymic neuroendocrine tumors in Japan and to clarify the characteristics of those patients
Basic objectives2	Others
Basic objectives -Others	Neuroendocrine Tumor
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Prognosis of the disease
Key secondary outcomes	Not Applicable

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) Patient with pathological diagnosis as defined below after Jan 1st 2012 who are receiving follow-up examination after institutional IRB/IEC approval a) NET G1/G2, NEC, or MANEC as pancreatic or gastroenteral neuroendocrine tumors b) TC (Typical carcinoid), AC (Atypical carcinoid), LCNEC (Large cell neuroendocrine carcinoma) as bronchopulmonary neuroendocrine tumors c) Any type of thymic neuroendocrine tumors 2) Patient with pancreatic, gastroenteral, bronchopulmonary, and thymic NET 3) Written informed consent (written informed consent from their parents or their legal representative who may represent their intent and interest will be needed when subjects are under 20 years old)
Key exclusion criteria	1) Patient with pathologically diagnosed small cell lung cancer (SCLC) as bronchopulmonary neuroendocrine tumors 2) Patients previously enrolled into this study 3) Patients regarded as ineligible for other reason by the investigator.
Target sample size	1800

Research contact person
Name of lead principal investigator	1st name Shinji Middle name Last name Uemoto
Organization	Kyoto University Hospital
Division name	Department of Surgery
Zip code	606-8507
Address	54 Shogoin Kawaharacho Sakyoku Kyoto
TEL	075-751-3242
Email	jnets-office@umin.ac.jp

Public contact
Name of contact person	1st name Toshihiko Middle name Last name Masui
Organization	Japan Neuroendocrine Tumor Society
Division name	Secretariat
Zip code	606-8507
Address	Kyoto Univerity, Department of Surgery, 54 Shogoin Kawaharacho Sakyoku Kyoto
TEL	075-751-3242
Homepage URL	http://jnets.umin.jp/index.html
Email	jnets-office@umin.ac.jp

Sponsor
Institute	Japan Neuroendocrine Tumor Society
Institute
Department

Funding Source
Organization	Japan Neuroendocrine Tumor Society
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Translational Research Center for Medical Innovation
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel	075-753-4642
Email	ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	TRINET1332
Org. issuing International ID_1	Translational Research Center for Medical Innovation
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	膵・消化管： 330施設 肺・気管支・胸腺： 25施設

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 31 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	Open public recruiting
Date of protocol fixation	2014 Year 12 Month 26 Day
Date of IRB	2015 Year 01 Month 14 Day
Anticipated trial start date	2015 Year 01 Month 23 Day
Last follow-up date	2024 Year 11 Month 30 Day
Date of closure to data entry	2024 Year 11 Month 30 Day
Date trial data considered complete	2024 Year 11 Month 30 Day
Date analysis concluded	2024 Year 11 Month 30 Day

Other
Other related information	The registration consists of basic questions. As this study is an exhaustive survey, we do not limit the schedule of observation or the treatment option.

Management information
Registered date	2015 Year 01 Month 29 Day
Last modified on	2021 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018910