UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028150
Receipt number R000032219
Scientific Title Analysis of apolipoprotein A2 isoform as a novel pancreatic exocrine marker
Date of disclosure of the study information 2017/07/10
Last modified on 2017/07/09 17:53:04

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Basic information

Public title

Analysis of apolipoprotein A2 isoform as a novel pancreatic exocrine marker

Acronym

Analysis of apolipoprotein A2 isoform as a novel pancreatic exocrine marker

Scientific Title

Analysis of apolipoprotein A2 isoform as a novel pancreatic exocrine marker

Scientific Title:Acronym

Analysis of apolipoprotein A2 isoform as a novel pancreatic exocrine marker

Region

Japan


Condition

Condition

Healthy volunteers, patients with chronic pancreatitis, patients with chronic hepatitis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the adaptation of apolipoprotein A 2 isoform, a novel pancreatic cancer marker, as an exocrine pancreatic marker.

Basic objectives2

Others

Basic objectives -Others

We will evaluate the adaptation of apolipoprotein A2 isoform, a novel pancreatic cancer marker, as an exocrine pancreatic marker.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Presence or absence of correlation between Pancreatic Functioning Diagnostant (PFD) test result which is a pancreatic exocrine function test and apolipoprotein A2 isoform,

Key secondary outcomes

Presence or absence of correlation between pancreatic fat percentage and apolipoprotein A2 isoform


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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Blood test and PFD test

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1.Healthy volunteers:
1) Volunteers who are 20 years old or older and under 75 years old when registering. Gender is male.
2) No history of pancreatic disease.
3) Currently not receiving internal treatment.
4) Consent is obtained in writing on participation of this research.
2.Patients with chronic pancreatitis: Patients who underwent a PFD test with reasons for insurance indication (suspected decline in pancreatic exocrine function). The age, sex does not matter.
3.fat-water MRI: Patient who took fat-water MRI with reasons for insurance indication (chronic liver disease). The age, sex does not matter.

Key exclusion criteria

1.Normal Volunteers: Exclusion criteria are as follows.
1: Cases where pancreatic diseases are merged.
2: In case of internal medication treatment. In the case of
3: Example of impaired renal function.
4: Example of acute hepatitis.
5: Case of alcohol sensitivity.
2.Patients with chronic pancreatitis: There is no special exclusion criteria.
3.fat - water MRI: Exclusion criteria are not specifically provided.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shingo Kato

Organization

Yokohama City University School of Medicine, Yokohama, Japan

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Japan

TEL

045-787-2800

Email

shin800m@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shingo Kato

Organization

Yokohama City University School of Medicine, Yokohama, Japan

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Japan

TEL

045-787-2800

Homepage URL


Email

shin800m@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

B170302007

Org. issuing International ID_1

Yokohama City University Hospital

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 10 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 07 Month 10 Day

Date of IRB


Anticipated trial start date

2017 Year 07 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 07 Month 09 Day

Last modified on

2017 Year 07 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032219


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name