UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025857 |
|---|---|
| Receipt number | 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 | 2021/01/29 12:04:53 |
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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
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
kobatak@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of gastroenterology, Department of internal medicine, Kobe university Graduate school of medicine
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6694/12/9/2625
Number of participants that the trial has enrolled
5120
Results
We enrolled 5120 subjects in experimental screening, with 84 subjects (1.3%) showing positive results for apoA2-ATQ/AT. Pancreatic abnormalities were recognized in 26 of the 84 subjects from imaging examinations. Pancreatic abnormalities detected included 1 PC and 15 HR abnormalities, such as cystic lesions including intraductal papillary mucinous neoplasm. The PPV of apoA2-ATQ/AT for detecting PC and HR was 33.3%.
Results date posted
| 2021 | Year | 01 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 09 | Month | 14 | Day |
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
| 2015 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 14 | Day |
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
| 2021 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029092
