UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021443 |
|---|---|
| Receipt number | 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 13:41:05 |
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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
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
atmasuda@med.kobe-u.ac.jp
Public contact
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
tnaka@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024731
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
