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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016380
Receipt No. R000018910
Scientific Title Nationwide registry for patients with pancreatic, gastroenteral, bronchopulmonary, and thymic neuroendocrine tumors in Japan
Date of disclosure of the study information 2015/01/31
Last modified on 2018/08/03

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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
Middle name
Last name Shinji Uemoto
Organization Kyoto University Hospital
Division name Department of Surgery
Zip code
Address 54 Shogoin Kawaharacho Sakyoku Kyoto
TEL 075-751-3242
Email jnets-office@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiko Masui
Organization Japan Neuroendocrine Tumor Society
Division name Secretariat
Zip code
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
Address
Tel
Email

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
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
Date trial data considered complete
Date analysis concluded

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
2018 Year 08 Month 03 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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