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

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 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

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

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


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