UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017752 |
|---|---|
| Receipt number | R000020562 |
| Scientific Title | Transjugular liver biopsy for liver damage after hematopoietic stem cell trasnplantation |
| Date of disclosure of the study information | 2015/05/31 |
| Last modified on | 2023/12/06 09:42:11 |
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Basic information
Public title
Transjugular liver biopsy for liver damage after hematopoietic stem cell trasnplantation
Acronym
Transjugular liver biopsy for liver damage after hematopoietic stem cell trasnplantation
Scientific Title
Transjugular liver biopsy for liver damage after hematopoietic stem cell trasnplantation
Scientific Title:Acronym
Transjugular liver biopsy for liver damage after hematopoietic stem cell trasnplantation
Region
| Japan |
Condition
Condition
liver damage after hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the safety and efficacy of transjugular liver biopsy for the patients after hematopoietic stem cell transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of definitive diagnosis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Transjugular liver biopsy was underwent with Liver access and biopsy set (Cook Medical).
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients after hematopoietic stem cell transplantation.
2. Age 16-65.
3. Liver damage.
Key exclusion criteria
1. Obvious cause of liver damage.
2. Can be applied to percutaneous liver biopsy.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Honda |
Organization
Univesity of Tokyo Hospital
Division name
Hematology and Oncology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
ahonda-spr@umin.org
Public contact
Name of contact person
| 1st name | Honda |
| Middle name | |
| Last name | Akira |
Organization
Univesity of Tokyo Hospital
Division name
Hematology and Oncology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
ahonda-spr@umin.org
Sponsor or person
Institute
Univesity of Tokyo Hospital,
Department of Hematology and Oncology
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo, Ethics Committee
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3815-5411(20818)
ethics@m.u-tokyo.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
| 2015 | Year | 05 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2009 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2009 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020562
