UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Smoking Status on the Incidence of Pancreatic Cancer Concomitant with Intraductal Papillary Mucinous Neoplasm, Invasive Intraductal Papillary Mucinous Neoplasm
Title of the study (Brief title)	Effect of Smoking Status on the Incidence of Pancreatic Cancer Concomitant with IPMN,Invasive IPMN
Region	Japan

Condition
Condition	intraductal papillary mucnous neoplasm:IPMN
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to elucidate the association of smoking status with the incidence of pancreatic cancer with IPMN and invasive IPMN.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the association of smoking status with the incidence of pancreatic cancer with IPMN and invasive IPMN
Key secondary outcomes	the association offamily history of pancreatic cancer(presence, absence), diabetes mellitus(presence, absence), alcohol consumption(more than 50g/day, less than 50g/day), BMI(more than 25, less than 25), macroscopic type of IPMN ,diameter of IPMN , nodule in IPMN (presence, absence),diameter of main pancreatic with the incidence of pancreatic cancer with IPMN and invasive IPMN

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	This study included patients with surgically resected IPMNs and PDAC concomitant with IPMN in Kobe university hospital between April 2008 to October 2015
Key exclusion criteria	nothing
Target sample size	124

Research contact person
Name of lead principal investigator	Atsuhiro Masuda
Organization	Kobe University Graduate School of Medicine
Division name	Division of Gastroenterology
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL	078-382-6305
Email	atmasuda@med.kobe-u.ac.jp

Public contact
Name of contact person	Takashi Nakagawa
Organization	Kobe University Graduate School of Medicine
Division name	Division of Gastroenterology
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL	078-382-6305
Homepage URL
Email	tnaka@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2016 Year 04 Month 15 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 03 Month 01 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	to elucidate the association of smoking status with the incidence of PDAC with IPMN and invasive, we will investigate retrospectively patients with surgically resected IPMNs and PDAC concomitant with IPMN.

Management information
Registered date	2016 Year 03 Month 11 Day
Last modified on	2017 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024731