UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044194
Receipt number 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 12:55:17

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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 or person

Institute

Department of Blood Transfusion and Transplantation Immunology, Fukushima Medical University

Institute

Department

Personal name



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

Value
https://center6.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