UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective study to identify prognostic markers of pancreatic cancer using biopsy samples
Title of the study (Brief title)	Study of prognostic markers of pancreatic cancer
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study was to investigate the use of the 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	Exploratory
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
Key exclusion criteria	(1) pancreatic cancer patients previously treated (2) patients who were suffering from any kind of malignancies including pancreatic cancer within 5 years (3) sever renal or liver dysfunction (4) individuals who did not accept informed consent (5) unsuitable individuals for this clinical study
Target sample size	30

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	088-880-2339
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	088-880-2339
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
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 07 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 05 Month 30 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 01 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Since many pancreatic cancer patients have already transferred to the another hospital, We will provide opportunities for refusal to participate in this study by opt-out. The medical institutions will disclose the opt-out document approved by the ethics committee in the manner prescribed by each medical institution. Samples and information of the subjects who expressed their refusal to participate in this study are not used for this study.

Management information
Registered date	2018 Year 06 Month 01 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=R000037440