UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of apolipoprotein A2 isoform as a novel pancreatic exocrine marker
Title of the study (Brief title)	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	Shingo Kato
Organization	Yokohama City University School of Medicine, Yokohama, Japan
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2800
Email	shin800m@yokohama-cu.ac.jp

Public contact
Name of contact person	Shingo Kato
Organization	Yokohama City University School of Medicine, Yokohama, Japan
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2800
Homepage URL
Email	shin800m@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 07 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032219