UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of prognostic factors for patients undergoing surgical resection for pancreatic cancer after pre-operative therapies, a retrospective study.
Title of the study (Brief title)	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	Itaru Endo
Organization	Yokohama city university, school of medicine
Division name	Dept of Gastroenterological Surgery
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	Yasuhiro Yabushita
Organization	Yokohama city university, school of medicine
Division name	Dept of Gastroenterological Surgery
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 01 Month 18 Day
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

Related information
URL releasing protocol	http://www.waaint.co.jp/jsps2017/03.html
Publication of results	Unpublished
URL releasing results
Results
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