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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027346
Receipt No. 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

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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
Email 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
Email yabu23@yokohama-cu.ac.jp

Sponsor
Institute Yokohama city university, school of medicine
Dept of Gastroenterological Surgery
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031337

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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