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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017958
Receipt No. R000020813
Scientific Title Developing a diagnostic method for pancreatic cancer at the very early stage
Date of disclosure of the study information 2015/06/18
Last modified on 2018/12/20

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Basic information
Public title Developing a diagnostic method for pancreatic cancer at the very early stage
Acronym Developping a diagnostic method for pancreatic cancer at the very early stage
Scientific Title Developing a diagnostic method for pancreatic cancer at the very early stage
Scientific Title:Acronym Developping a diagnostic method for pancreatic cancer at the very early stage
Region
Japan

Condition
Condition Intraductal papillary mucinous neoplasm (IPMN), Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Developing the diagnostic method for pancreatic cancer at the very early stage
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Better diagnostic performance is obtained than existing tumor markers
Key secondary outcomes

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 The consent for registration is obtained
Key exclusion criteria The consent for registration is not understood
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Hagihara
Organization Osaka City University
Division name Department of Hepatology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL 06-6645-3811
Email hagy@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Hagihara
Organization Osaka City University
Division name Department of Hepatology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL 06-6645-3811
Homepage URL
Email hagy@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization MHLW/AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 大阪市立大学(大阪府)、京都大学(京都府)、国立がん研究センター(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 18 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 Enrolling by invitation
Date of protocol fixation
2014 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 26 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information Developing the diagnotic method for pancreatic cancer at very early stage, utilizing the relation between expression of micro RNA and status of DNA methylation

Management information
Registered date
2015 Year 06 Month 18 Day
Last modified on
2018 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020813

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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