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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028015
Receipt No. R000032076
Scientific Title The feasibility study for pancreatic cancer screening by plasma biomarker using apoA2-isoforms.
Date of disclosure of the study information 2017/07/04
Last modified on 2019/07/03

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Basic information
Public title The feasibility study for pancreatic cancer screening by plasma biomarker using apoA2-isoforms.
Acronym Feasibility study of apoA2-i
Scientific Title The feasibility study for pancreatic cancer screening by plasma biomarker using apoA2-isoforms.
Scientific Title:Acronym Feasibility study of apoA2-i
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to get the proof of concept of the efficient screening method pancreatic cancer screening. We will calculate the of samples that need in next the randomized trial from the result of this study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Ditection rate of the pancreatic cancer
Key secondary outcomes Detection rate and positive predictive value of the pancreatic disorders including pancreatic cancer. 2. Survival time and mortality.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 The first screening of pancreatic cancer by plasma apoA2-i. The second screening of pancreatic cancer by enhanced CT.
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. The subjects undergo the specific examination, job area examination, and multiphasic health screening in the specific screening institutes.
2. The subjects are more than 50 years old.
3. The subjects were not diagnosed before enrolled for thus study, with autoimmune pancreatitis, pancreatic intraepithelial neoplasia, intraductal papillary mucinous neoplasm, mucinous cystic neoplasm, pancreatic neuroendocrine tumor and Solid-pseudopapillary neoplasm.
4. The subjects are agreeing to participate in this study with a documentation.
Key exclusion criteria 1. The subjects underwent the pancreatectomy.
2. The subjects have undergone the treatmet for maligant disorders other than pancreatic cancer.
3. The subjects have the serious disorders, and 5-years survival cannot expect.
4. The subjects with the reasons which the medical institutions considered as inadequacy.
Target sample size 20000

Research contact person
Name of lead principal investigator
1st name kazufumi
Middle name
Last name Honda
Organization National Cancer Center Research Institute
Division name Department of Biomarker for Early Detection of Cancer
Zip code 1040045
Address 5-1-1 Tsukiji Chuoku Tokyo 104-0045, Japan
TEL 03-3542-2511
Email khonda@ncc.go.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Konishi
Organization Japan Cancer Society
Division name Group of Cancer Screening
Zip code 1040061
Address 9F 7-16-12 Ginza Chuo-ku Tokyo Japan
TEL 03-3541-4771
Homepage URL
Email konishihiroshi@gmail.com

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center Hospital Certified Review Board
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
Tel 03-3542-2511
Email ncch-irb@ml.res.ncc.go.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 鹿児島県民総合保健センター、鹿児島大学、鹿児島市立病院、出水市総合医療センター、ホテルオークラ神戸クリニック、神戸大学医学部附属病院、北海道対がん協会がん検診センター、北海道大学病院

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 04 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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 21 Day
Date of IRB
2017 Year 06 Month 21 Day
Anticipated trial start date
2017 Year 07 Month 04 Day
Last follow-up date
2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 30 Day
Last modified on
2019 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032076

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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