UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028878 |
|---|---|
| Receipt number | R000033043 |
| Scientific Title | Observational study of early onset DIC in the pediatric hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2021/03/02 17:25:04 |
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Basic information
Public title
Observational study of early onset DIC in the pediatric hematopoietic stem cell transplantation
Acronym
DIC-SCT15
Scientific Title
Observational study of early onset DIC in the pediatric hematopoietic stem cell transplantation
Scientific Title:Acronym
DIC-SCT15
Region
| Japan |
Condition
Condition
hematologically malignant diseases
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relation of DIC and other transplantation-related complications by collection of the clinical information of early onset DIC in SCT
Basic objectives2
Others
Basic objectives -Others
To evaluate the safety and effectiveness of recombinant thrombomodulin for DIC in SCT
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Risk factors of DIC and its frequency
Key secondary outcomes
The relation of transplantation-related mortality and morbidity with DIC
The rate of improvement of DIC one week after the onset of DIC and its poor prognostic factors
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
| 0 | years-old | <= |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age between 0 to 20 years old
One who will receive allogeneic stem cell transplantation
One who is enrolled in CHM-14 study
One who has written agreement or ascent by oneself or from the guardians for this study
Key exclusion criteria
nothing particular
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Nagasawa |
Organization
Musashino Red Cross Hospital
Division name
Pediatrics
Zip code
180-8610
Address
1-26-1 Kyonan-cho, Musashino-city, Tokyo
TEL
0422-32-3111
mnagasawa.ped@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Nagasawa |
Organization
Musashino Red Cross Hospital
Division name
Department of Pediatrics
Zip code
180-8610
Address
1-26-1 Kyonan-cho, Musashino-city,Tokyo
TEL
0422-32-3111
Homepage URL
mnagasawa.ped@tmd.ac.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Asahi Kasei Pharma Corporation
IRB Contact (For public release)
Organization
Musashino Red Cross Hospital Institutional Review Board
Address
1-26-1, Kyonan-cho, Musashino-city, Tokyo
Tel
0422-32-3111 ext 6812
shimozu@musashino.jrc.or.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 | 09 | 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
13
Results
Results date posted
Results Delayed
Results Delay Reason
Analysis could not be done due to the extremely shortage of enrolled cases.
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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2017 | Year | 08 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033043
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
