UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016380 |
|---|---|
| Receipt number | 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 | 2021/02/04 15:43:12 |
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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 | 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
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
jnets-office@umin.ac.jp
Sponsor or person
Institute
Japan Neuroendocrine Tumor Society
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018910
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
