UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011646 |
|---|---|
| Receipt number | R000013616 |
| Scientific Title | Japanese Survey of Adverse Reaction by Hematopoietic Cell Transplantation |
| Date of disclosure of the study information | 2013/09/05 |
| Last modified on | 2017/09/13 07:48:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Japanese Survey of Adverse Reaction by Hematopoietic Cell Transplantation
Acronym
Survey of Adverse Reaction by Hematopoietic Cell Transplantation
Scientific Title
Japanese Survey of Adverse Reaction by Hematopoietic Cell Transplantation
Scientific Title:Acronym
Survey of Adverse Reaction by Hematopoietic Cell Transplantation
Region
| Japan |
Condition
Condition
hematologic malignancies and bone marrow failure
Classification by specialty
| Hematology and clinical oncology | Blood transfusion | Adult |
| Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is to clarify types, frequencies, and severity of the adverse reactions in the hematopoietic stem cell (HSC) transplantation due to contaminated or redundant components such as DMSO, HES, anti-coagulants, and hematopoietic cells other than HSCs in the infused products.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numbers of infused cells and types and frequencies of adverse reactions.
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 who will require autologous peripheral blood stem cell transplantation (PBSCT) or donors for allogeneic PBSCT will be eligible if they undergo PBSCH. Written informed consent is required, and enrollees should be 18 years or older.
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Ohto |
Organization
Fukushima Medical University
Division name
Department of Blood Transfusion and Transplantation Immunology
Zip code
Address
1 Hikariga-oka, Fukushima
TEL
024-547-1536
hit-ohto@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Ikeda |
Organization
Fukushima Medical University
Division name
Department of Blood Transfusion and Transplantation Immunology
Zip code
Address
1 Hikariga-oka, Fukushima
TEL
024-547-1536
Homepage URL
kazu-ike@fmu.ac.jp
Sponsor or person
Institute
Japan Society of Blood Transfusion and Cell Therapy
Institute
Department
Personal name
Funding Source
Organization
none
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
福島県立医科大学病院、慶應義塾大学病院、名古屋第一赤十字病院、国立がん研究センター、自治医科大学病院、東京大学医科学研究所、広島大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 05 | 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
| 2013 | Year | 08 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 04 | Month | 01 | Day |
Other
Other related information
Age, sex, diagnosis, blood type, blood transfusion history, general findings, adverse reaction, infused cell count will be investigated.
Management information
Registered date
| 2013 | Year | 09 | Month | 03 | Day |
Last modified on
| 2017 | 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=R000013616
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
