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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028150
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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