UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027346 |
|---|---|
| Receipt number | R000031337 |
| Scientific Title | Evaluation of prognostic factors for patients undergoing surgical resection for pancreatic cancer after pre-operative therapies, a retrospective study. |
| Date of disclosure of the study information | 2017/05/15 |
| Last modified on | 2017/05/15 15:56:40 |
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Basic information
Public title
Evaluation of prognostic factors for patients undergoing surgical resection for pancreatic cancer after pre-operative therapies, a retrospective study.
Acronym
Evaluation of prognostic factors for patients undergoing surgical resection for pancreatic cancer after pre-operative therapies, a retrospective study.
Scientific Title
Evaluation of prognostic factors for patients undergoing surgical resection for pancreatic cancer after pre-operative therapies, a retrospective study.
Scientific Title:Acronym
Evaluation of prognostic factors for patients undergoing surgical resection for pancreatic cancer after pre-operative therapies, a retrospective study.
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluation of prognostic factors for patients undergoing surgical resection for pancreatic cancer after pre-operative therapies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Survival
Key secondary outcomes
Disease free survival, recurrence
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Diagnosed as pancreatic cancer histologically
(2) Performed surgical resection for pancreatic cancer after pre-operative therapies
(3) Adequate organ function
Key exclusion criteria
1) Men who refuse to participate in the study
2) Men whom researchers judge to inappropriate to participate in the study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Itaru Endo |
Organization
Yokohama city university, school of medicine
Division name
Dept of Gastroenterological Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa
TEL
045-787-2650
endoit@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Yabushita |
Organization
Yokohama city university, school of medicine
Division name
Dept of Gastroenterological Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa
TEL
045-787-2650
Homepage URL
http://www.waaint.co.jp/jsps2017/index.html
yabu23@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university, school of medicine
Dept of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japanese Society of Pancreatic Surgery
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
横浜市立大学 医学部（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
http://www.waaint.co.jp/jsps2017/03.html
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Retrospective study
Management information
Registered date
| 2017 | Year | 05 | Month | 15 | Day |
Last modified on
| 2017 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031337
| 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 |
