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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014421
Receipt No. R000016780
Scientific Title Prospective cohort study for gastroenteropancreatic neuroendocrine tumor
Date of disclosure of the study information 2014/06/30
Last modified on 2014/06/30

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Basic information
Public title Prospective cohort study for gastroenteropancreatic neuroendocrine tumor
Acronym Prospective cohort study for GEP-NET
Scientific Title Prospective cohort study for gastroenteropancreatic neuroendocrine tumor
Scientific Title:Acronym Prospective cohort study for GEP-NET
Region
Japan

Condition
Condition gastroenteropancreatic neuroendocrine tumor
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to accumulate prospectively the clinical feature of the patients who was treated with gastroentero-pancreatic neuroendocrine tumor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes disease free survival
Key secondary outcomes overall survival

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 All the patients who treated with gastroenteropancreatic neuroendocrine tumor in the participating institutes
Key exclusion criteria N/A
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Unno
Organization Tohoku University Hospital
Division name Hepato-Biliary Pancreatic surgery
Zip code
Address 1-1 Seiryo-cho, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7205
Email m_unno@surg1.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Aoki
Organization Tohoku University Hospital
Division name Hepato-Biliary Pancreatic surgery
Zip code
Address 1-1 Seiryo-cho, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7205
Homepage URL http://www.surg1.med.tohoku.ac.jp/
Email takegogo13@gmail.com

Sponsor
Institute Departent of Surgery, Tohoku University
Institute
Department

Funding Source
Organization Tohoku University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 仙台オープン病院(宮城県)、仙台厚生病院(宮城県)、山形県立中央病院(山形県)、仙台医療センター(宮城県)、東北労災病院(宮城県)、宮城県南中核病院(宮城県)、JCHO仙台南病院(宮城県)、東北薬科大学病院(宮城県)、十和田市立中央病院(青森県)、塩竈市立病院(宮城県)、仙台徳洲会病院(宮城県)、白河厚生総合病院(福島県)、宮城県立がんセンター(宮城県)、いわき市立総合磐城共立病院(福島県)仙北組合総合病院(秋田県)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 30 Day

Related information
URL releasing protocol http://www.surg1.med.tohoku.ac.jp/
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 Enrolling by invitation
Date of protocol fixation
2014 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 30 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Primary lesion
Treatment (Operation)
pathological diagnosis
recurrence or not
disease free survival
treatment for the recurrence
Overall survival

Management information
Registered date
2014 Year 06 Month 30 Day
Last modified on
2014 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016780

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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