UMIN-CTR Clinical Trial

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
Email	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
Email	takahito181@gmail.com

Sponsor
Institute	Diagnostic Center for Sonography, Hokkaido University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051344