UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028015 |
|---|---|
| Receipt number | 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 | 2024/01/12 13:35:47 |
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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
NIPPONMEDICALSCHOOL
Division name
biodynamics
Zip code
113-8602
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
k-honda@nms.ac.jp
Public contact
Name of contact person
| 1st name | ayumi |
| Middle name | |
| Last name | kashiro |
Organization
NIPPONMEDICALSCHOOL
Division name
biodynamics
Zip code
113-8602
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
a-kashiro@nms.ac.jp
Sponsor or person
Institute
NIPPONMEDICALSCHOOL
Institute
Department
Personal name
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
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
15000
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
| 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
| 2024 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032076
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/01/12 | 革新第７版計画書修正 AK20230110.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/01/12 | 新規 Microsoft Excel ワークシート.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/01/12 | 新規 Microsoft Excel ワークシート.xlsx |
