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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
