UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043091 |
|---|---|
| Receipt number | R000047780 |
| Scientific Title | Multicenter prospective observational trial for diagnosing sinusoidal obstruction syndrom/veno occlusive disease by Hokkaido ultrasonography based scoring system |
| Date of disclosure of the study information | 2021/01/26 |
| Last modified on | 2022/05/09 16:47:07 |
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Basic information
Public title
Multicenter trial for diagnosing sinusoidal obstruction syndrom/veno occlusive disease by ultrasonography
Acronym
HokUS-10 trial
Scientific Title
Multicenter prospective observational trial for diagnosing sinusoidal obstruction syndrom/veno occlusive disease by Hokkaido ultrasonography based scoring system
Scientific Title:Acronym
HokUS-10 trial
Region
| Japan |
Condition
Condition
Sinusoidal obstruction syndrom/ veno occlusive disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Radiology | Laboratory medicine | Blood transfusion |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluating efficacy of Hokkaido US based scoring system (HokUS-10/6) for early diagnosing SOS/VOD by multicenter prospective observational trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic performance of HokUS-10/6 for diagnosing SOS/VOD compare to clinical diagnosis as a gold standard
Key secondary outcomes
1 Clinical course of SOS/VOD and transition of HokUS-10/6
2 Onset prediction by base line HokUS-10/6 score before HSCT
3 Comparing the diagnosis date of HokUS-10/6 with clinical diagnosis
4 Evaluation of SOS/VOD severity by HokUS10/6
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
| 1 | months-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Able to have ultrasonography
Informed consent is obtained after enough explanation by adult patient or substitute if minors.
Key exclusion criteria
Autotransplant patients
Not having ultrasonography safely
Not suitable having ultrasonography
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Mutsumi |
| Middle name | |
| Last name | Nishida |
Organization
Hokkaido University Hospital
Division name
Department of planning and management
Zip code
0608648
Address
N.15, W. 4, Kita-ku, Sapporo
TEL
+81-011-706-5697
mutuni@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Goto |
Organization
Hokkaido University Hospital
Division name
Division of Laboratory and Transfusion Medicine
Zip code
0608648
Address
N.15, W. 4, Kita-ku, Sapporo
TEL
+81-011-706-7784
Homepage URL
hidekigt@med.hokudai.ac.jp
Sponsor or person
Institute
Diagnostic Center for Sonography, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Shinyaku Co. Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tohoku University Hospital
Fukushima Medical University Hospital
National Cancer Center Hospital
Kobe University Hospital
Okayama University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Hokkaido University Hospital
Address
N.14, W.5, Kita-ku, Sapporo
Tel
+81-011-706-7636
crjimu@huhp.hokudai.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
東北大学病院
福島県立医科大学附属病院
国立がん研究センター中央病院
神戸大学医学部附属病院
岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 26 | 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
400
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
| 2021 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients having HSCT in institutions attending this trial
Management information
Registered date
| 2021 | Year | 01 | Month | 22 | Day |
Last modified on
| 2022 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047780
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/01/26 | 【承認版】小児同意文書2（小児）.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
