UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045423 |
|---|---|
| Receipt number | R000051344 |
| Scientific Title | Transabdominal ultrasonographical scoring system diagnosing for late onset sinusoidal obstruction syndrome/ veno occlusive disease, sigle center retrospective study |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2022/09/13 16:06:25 |
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Basic information
Public title
Transabdominal ultrasonographical scoring system diagnosing for late onset sinusoidal obstruction syndrome/ veno occlusive disease
Acronym
Late onset SOS/VOD diagnosis by HokUS-10/6
Scientific Title
Transabdominal ultrasonographical scoring system diagnosing for late onset sinusoidal obstruction syndrome/ veno occlusive disease, sigle center retrospective study
Scientific Title:Acronym
Late onset SOS/VOD diagnosis by HokUS-10/6, single center retrospective study
Region
| Japan |
Condition
Condition
Sinusoidal obstruction syndrome/ veno-occlusive disease after HSCT
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Diagnosis of late onset SOS/VOD by scoring transabdominal ultrasonography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic performance of late onset SOS/VOD by scoring transabdominal ultrasonography
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 diagnosed having hematologic disease who underwent allogeneic HSCT at Hokkaido University Hospital were enrolled. US was performed before conditioning therapy (pre-HSCT) and on day 28 after HSCT.
Key exclusion criteria
Patients not having ultrasonography 22 days after HSCT
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
Diagnostic Center for Sonography
Zip code
060-8648
Address
N.14, W.5, Kita-ku, Sapporo, Japan
TEL
+81-11-716-1161
mutuni@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Iwai |
Organization
Hokkaido University Hospital
Division name
Diagnostic Center for Sonogrphy
Zip code
0608648
Address
N.15, W.5., kita-ku Sapporo
TEL
011-716-1161
Homepage URL
takahito181@gmail.com
Sponsor or person
Institute
Diagnostic Center for Sonography, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Diagnostic center for sonography, Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
N.14. W.5, Kita-ku Sapporo
Tel
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non
Management information
Registered date
| 2021 | Year | 09 | Month | 08 | Day |
Last modified on
| 2022 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051344
