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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044194
Receipt No. R000050462
Scientific Title Prospective observational study of correlation between hematopoietic cell infusion-related adverse events and post-transplant complications.
Date of disclosure of the study information 2021/06/30
Last modified on 2021/11/15

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Basic information
Public title Prospective observational study of correlation between hematopoietic cell infusion-related adverse events and post-transplant complications.
Acronym Prospective observational study of correlation between hematopoietic cell infusion-related adverse events and post-transplant complications.
Scientific Title Prospective observational study of correlation between hematopoietic cell infusion-related adverse events and post-transplant complications.
Scientific Title:Acronym Prospective observational study of correlation between hematopoietic cell infusion-related adverse events and post-transplant complications.
Region
Japan

Condition
Condition Recipient of hematopoietic stem cell transplantation
Classification by specialty
Hematology and clinical oncology Blood transfusion
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will clarify the impact of adverse events associated with hematopoietic stem cell transplantation (HSCT) on survival and the incidence of various complications after HSCT.
In addition, we will provide basic data for the establishment of a biovigilance system for HSCT in the future.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of complications (PIR, Engraftment failure, TMA, VOD/SOS, GVHD, or Viral Infection) at 100 days after transplantation in association with hematopoietic cell infusion-related adverse events.
Key secondary outcomes 2-year overall survival by incidences of hematopoietic cell infusion-related adverse events

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All allogenic hematopoietic stem cell infusion performed on 15 years of age or older at participating institution.
Key exclusion criteria (1)Patients whose consent for this study are not available.
(2)Patient who disagree to the survey Transplant Registry Unified Management Program.
(3)Donor Lymphocyte Infusion
(4) Autologous transplantation
(5) Other patients who are judged by the physician in charge to be inappropriate for this study.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name kazuhiko
Middle name
Last name ikeda
Organization Fukushima Medical University
Division name Department of Blood Transfusion and Transplantation Immunology
Zip code 960-1295
Address Hikarigaoka 1, Fukushima, Fukushima, Japan
TEL 024-547-1536
Email kazu-ike@fmu.ac.jp

Public contact
Name of contact person
1st name Keiji
Middle name
Last name Minakawa
Organization Fukushima Medical University Hospital
Division name Department of Blood Transfusion and Transplantation Immunology
Zip code 960-1295
Address Hikarigaoka 1,Fukushima, Fukushima, Japan
TEL 024-547-1536
Homepage URL
Email inf-hsct@fmu.ac.jp

Sponsor
Institute Department of Blood Transfusion and Transplantation Immunology, Fukushima Medical University
Institute
Department

Funding Source
Organization KYOKUTO PHARMACEUTICAL INDUSTRIAL CO., LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukushima Medical University
Address Hikarigaoka 1, Fukushima, Fukushima, Japan
Tel 024-547-1111
Email inf-hsct@fmu.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 福島県立医科大学附属病院

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 30 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 Enrolling by invitation
Date of protocol fixation
2021 Year 01 Month 18 Day
Date of IRB
2021 Year 03 Month 16 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2026 Year 03 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
2021 Year 05 Month 12 Day
Last modified on
2021 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050462

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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