UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014421 |
|---|---|
| Receipt number | 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 12:12:07 |
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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
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/
takegogo13@gmail.com
Sponsor or person
Institute
Departent of Surgery, Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016780
| Research Plan | |
|---|---|
| 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 |
