UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009561 |
|---|---|
| Receipt number | R000011217 |
| Scientific Title | The collection of sera of healthy subjects for investigation of growth factors in chronic liver diseases, hepatocellular carcinoma, and pancreatic cancer |
| Date of disclosure of the study information | 2012/12/16 |
| Last modified on | 2012/12/16 16:54:06 |
* 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
The collection of sera of healthy subjects for investigation of growth factors in chronic liver diseases, hepatocellular carcinoma, and pancreatic cancer
Acronym
The collection of sera of healthy subjects for investigation of growth factors in chronic liver diseases, hepatocellular carcinoma, and pancreatic cancer
Scientific Title
The collection of sera of healthy subjects for investigation of growth factors in chronic liver diseases, hepatocellular carcinoma, and pancreatic cancer
Scientific Title:Acronym
The collection of sera of healthy subjects for investigation of growth factors in chronic liver diseases, hepatocellular carcinoma, and pancreatic cancer
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to collect sera of healthy subjects to compare precisely with sera of the patients with chronic liver diseases, hepatocellular carcinoma, or pancreatic cancer.
Basic objectives2
Others
Basic objectives -Others
The aim is to compare protein levels in the sera of the patients and healthy subjects as controls.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The exploration of specific proteins involved in the progression of the diseases
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All healthy subjects do not have diagnoses of chronic liver diseases including viral hepatitis and NASH, and do not have any malignancies.
Key exclusion criteria
Pregnant females and the patients who have severe infectious diseases.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohide Tatsumi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 16 | 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
| 2012 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The items to be examined in healthy subjects are described below.
Age, sex, height, body weight, past history
Management information
Registered date
| 2012 | Year | 12 | Month | 16 | Day |
Last modified on
| 2012 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011217
