UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013335 |
|---|---|
| Receipt number | R000015563 |
| Scientific Title | Retrospective analysis study on the prognosis of patients with resectable pancreatic neuroendocrine tumors |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2014/03/04 22:23:17 |
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Basic information
Public title
Retrospective analysis study on the prognosis of patients with resectable pancreatic neuroendocrine tumors
Acronym
Retrospective analysis of patients with resectable pancreatic neuroendocrine tumors
Scientific Title
Retrospective analysis study on the prognosis of patients with resectable pancreatic neuroendocrine tumors
Scientific Title:Acronym
Retrospective analysis of patients with resectable pancreatic neuroendocrine tumors
Region
| Japan |
Condition
Condition
pancreatic neuroendocrine tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the factors related with the prognosis and relations the results of contrast enhanced computed tomography (CECT) and prognosis.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Compare the enhancement pattern of CECT and their malignant potential from pathological findings
Key secondary outcomes
1) Compare the enhancement pattern of CECT and detailed pathological findings
2) Relation between the enhancement pattern of CECT and prognosis
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
| 10 | years-old | < |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with resected pancreatic neuroendocrine tumors
Key exclusion criteria
unresectable cases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuzo Kodama |
Organization
Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kawahara-cho54, Shogoin, Sakyopku, Kyoto, Japan
TEL
075-751-4319
kodamayu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Kurita |
Organization
Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kawahara-cho54, Shogoin, Sakyopku, Kyoto, Japan
TEL
075-751-4319
Homepage URL
akurita@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 01 | 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 | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
retrospective study
Management information
Registered date
| 2014 | Year | 03 | Month | 04 | Day |
Last modified on
| 2014 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015563
