UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030348 |
|---|---|
| Receipt number | R000034554 |
| Scientific Title | Study for apoptosis inhibitor of macrophage (Free AIM) for the prediction of hepatocellular carcinoma. |
| Date of disclosure of the study information | 2017/12/11 |
| Last modified on | 2022/06/15 14:40:54 |
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Basic information
Public title
Study for apoptosis inhibitor of macrophage (Free AIM) for the prediction of hepatocellular carcinoma.
Acronym
Diagnostic performance of Free AIM for HCC
Scientific Title
Study for apoptosis inhibitor of macrophage (Free AIM) for the prediction of hepatocellular carcinoma.
Scientific Title:Acronym
Diagnostic performance of Free AIM for HCC
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate predictive performance of Free AIM for hepatocellular carcinoma
Basic objectives2
Others
Basic objectives -Others
utility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the efficacy of plasma concentration of Free AIM for hepatocellular carcinoma
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic hepatitis/cirrhosis/hepatocellular carcinoma who have given written informed consent for preservation of serum sample for research purpose
Key exclusion criteria
none
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | none |
| Last name | Tateishi |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0338155411
masayasato0407@gmail.com
Public contact
Name of contact person
| 1st name | Sato |
| Middle name | none |
| Last name | Masaya |
Organization
The University of Tokyo
Division name
Department of Clinical Laboratory Medicine
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0338155411
Homepage URL
masayasato0407@gmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Sekisui medical CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sekisui medical CO., LTD
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital
Address
7-3-1, Hongo, Bunkyo ku
Tel
03-3815-5411
CReSjimu-tokyo@umin.ac.jp
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
| 2017 | Year | 12 | Month | 11 | 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
74
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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Website for opt-out statement
Management information
Registered date
| 2017 | Year | 12 | Month | 11 | Day |
Last modified on
| 2022 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034554
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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