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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025857
Receipt No. R000029092
Scientific Title Evaluation of apolipoprotein A2 isoforms and discovery of disease biomarkers by multi-omics study in population of medical checkups
Date of disclosure of the study information 2017/01/26
Last modified on 2019/05/15

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Basic information
Public title Evaluation of apolipoprotein A2 isoforms and discovery of disease biomarkers by multi-omics study in population of medical checkups
Acronym Evaluation of apolipoprotein A2 isoforms in medical checkups
Scientific Title Evaluation of apolipoprotein A2 isoforms and discovery of disease biomarkers by multi-omics study in population of medical checkups
Scientific Title:Acronym Evaluation of apolipoprotein A2 isoforms in medical checkups
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of diagnostic performance of the apolipoprotein AII isoforms for pancreatic cancer and its risk diseases.
Basic objectives2 Others
Basic objectives -Others Investigation of the clinical factors related to the apolipoprotein AII isoforms.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Positive predictive value of apolipoprotein AII isoforms for pancreatic cancer and its risk diseases in cancer screening
Key secondary outcomes Correlation between the value of apolipoprotein AII isoforms and the clinical background factors

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 over 20 years old
Key exclusion criteria none
Target sample size 20000

Research contact person
Name of lead principal investigator
1st name Masaru
Middle name
Last name Yoshida
Organization Kobe university
Division name gastroenterology
Zip code 6500017
Address 7-5-1, kusunoki-cho, chuo-ku, Kobe, Hyogo, Japan
TEL 078-382-6305
Email myoshida@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Kobayashi
Organization Kobe university
Division name gastroenterology
Zip code 6500017
Address 7-5-1, kusunoki-cho, chuo-ku, Kobe, Hyogo, Japan
TEL 078-382-6305
Homepage URL
Email kobatak@med.kobe-u.ac.jp

Sponsor
Institute Division of gastroenterology, Department of internal medicine, Kobe university Graduate school of medicine
Institute
Department

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

Other related organizations
Co-sponsor National Cancer Center Japan & Toray Industries, Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe university
Address 7-5-1, kusunoki-cho, chuo-ku, Kobe, Hyogo, Japan
Tel 078-382-6669
Email kansatsu@med.kobe-u.ac.jp

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 北播磨総合医療センター(兵庫県)、朝原クリニック(兵庫県)、淀川キリスト教病院(大阪府)、ホテルオークラ神戸クリニック(兵庫県)、京都第二赤十字病院(京都府)、済生会中津病院(大阪府)、福井赤十字病院(福井県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 26 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 No longer recruiting
Date of protocol fixation
2015 Year 04 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 10 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 none

Management information
Registered date
2017 Year 01 Month 26 Day
Last modified on
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029092

Research Plan
Registered date File name
2017/07/28 1716_PRT等_20160802.xls

Research case data specifications
Registered date File name

Research case data
Registered date File name


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