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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021443
Receipt No. R000024731
Scientific Title Effect of Smoking Status on the Incidence of Pancreatic Cancer Concomitant with Intraductal Papillary Mucinous Neoplasm, Invasive Intraductal Papillary Mucinous Neoplasm
Date of disclosure of the study information 2016/04/15
Last modified on 2017/02/22

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Basic information
Public title Effect of Smoking Status on the Incidence of Pancreatic Cancer Concomitant with Intraductal Papillary Mucinous Neoplasm, Invasive Intraductal Papillary Mucinous Neoplasm
Acronym Effect of Smoking Status on the Incidence of Pancreatic Cancer Concomitant with IPMN,Invasive IPMN
Scientific Title Effect of Smoking Status on the Incidence of Pancreatic Cancer Concomitant with Intraductal Papillary Mucinous Neoplasm, Invasive Intraductal Papillary Mucinous Neoplasm
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Atsuhiro Masuda
Organization Kobe University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL 078-382-6305
Email atmasuda@med.kobe-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takashi Nakagawa
Organization Kobe University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 15 Day

Related information
URL releasing protocol
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 Main results already published
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
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

Other
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

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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