UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study to identify prognostic markers of pancreatic cancer
Title of the study (Brief title)	Identification of preoperative and postoperative prognostic markers of pancreatic cancer
Region	Japan

Condition
Condition	pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to investigate the use of the preoperative and postoperative prognostic factors as useful markers for the poor prognosis of pancreatic cancer patients.
Basic objectives2	Others
Basic objectives -Others	To determine whether the prognostic factors are useful to predict the prognosis of pancreatic cancer patients
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Disease-Free 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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	(1) more than 20 years old and less than 90 years old (2) pancreatic cancer patients newly diagnosed and previously untreated (3) surgically-adapted pancreatic cancer patients
Key exclusion criteria	(1) pancreatic cancer patients previously treated (2) non-surgically-adapted pancreatic cancer patients (3) patients who were suffering from any kind of malignancies including pancreatic cancer within 5 years (4) sever renal or liver dysfunction (5) individuals who did not accept informed consent (6) unsuitable individuals for this clinical study
Target sample size	150

Research contact person
Name of lead principal investigator	Keisuke Taniuchi
Organization	Kochi Medical School Hospital, Kochi University
Division name	Department of Gastroenterology and Hepatology
Address	Kohasu, Oko-cho, Nankoku, Kochi
TEL	088-880-2338
Email	ktaniuchi@kochi-u.ac.jp

Public contact
Name of contact person	Keisuke Taniuchi
Organization	Kochi Medical School Hospital, Kochi University
Division name	Department of Gastroenterology and Hepatology
Address	Kohasu, Oko-cho, Nankoku, Kochi
TEL	088-880-2338
Homepage URL
Email	ktaniuchi@kochi-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Kochi Medical School Hospital, Kochi University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kanagawa Cancer Center Tokyo Metropolitan Tama Medical Center
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

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 09 Month 01 Day
Anticipated trial start date	2018 Year 10 Month 31 Day
Last follow-up date	2025 Year 06 Month 30 Day
Date of closure to data entry	2025 Year 07 Month 31 Day
Date trial data considered complete	2025 Year 09 Month 30 Day
Date analysis concluded	2025 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study was approved by the ethical review boards of Kochi Medical School, Kanagawa Cancer Center and Tokyo Metropolitan Tama Medical Center prior to patient recruitment. Written informed consent was acquired from each patient prior to initiation.

Management information
Registered date	2018 Year 09 Month 04 Day
Last modified on	2018 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038787