UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007394 |
|---|---|
| Receipt number | R000008716 |
| Scientific Title | Analysis of various biomarkers in DIC patients with hypercytokinemia after hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2012/02/28 |
| Last modified on | 2024/08/15 10:23:41 |
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Basic information
Public title
Analysis of various biomarkers in DIC patients with hypercytokinemia after hematopoietic stem cell transplantation
Acronym
Analysis of various biomarkers in DIC patients with hypercytokinemia after hematopoietic stem cell transplantation
Scientific Title
Analysis of various biomarkers in DIC patients with hypercytokinemia after hematopoietic stem cell transplantation
Scientific Title:Acronym
Analysis of various biomarkers in DIC patients with hypercytokinemia after hematopoietic stem cell transplantation
Region
| Japan |
Condition
Condition
Stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the relationship between the clinical events and markers using peripheral blood at pre- and post-SCT treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of biomarkers
Key secondary outcomes
efficacy of rTM
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ricomudurin
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
1) stem cell transplantation
2) Written Informed Consent
Key exclusion criteria
Decision of ineligibility by a physician.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shosaku Nomura |
Organization
Kansai Medical University
Division name
First Department of Internal Medicine
Zip code
Address
10-15, Fumizono-cho, Moriguchi City, Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shosaku Nomura |
Organization
Kansai Medical University
Division name
First Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
nomurash@hirakata.kmu.ac.jp
Sponsor or person
Institute
First Department of Internal Medicine,Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
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
Address
Tel
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
| 2012 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2011 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 28 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008716
