UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013332
Receipt number R000015561
Scientific Title The Efficacy and Long-term Outcomes of ASCT in POEMS Syndrome: A Multicenter Retrospective Study in Japan
Date of disclosure of the study information 2014/03/05
Last modified on 2018/10/06 07:58:59

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Basic information

Public title

The Efficacy and Long-term Outcomes of ASCT in POEMS Syndrome: A Multicenter Retrospective Study in Japan

Acronym

The Efficacy and Long-term Outcomes of ASCT in POEMS Syndrome: A Multicenter Retrospective Study in Japan

Scientific Title

The Efficacy and Long-term Outcomes of ASCT in POEMS Syndrome: A Multicenter Retrospective Study in Japan

Scientific Title:Acronym

The Efficacy and Long-term Outcomes of ASCT in POEMS Syndrome: A Multicenter Retrospective Study in Japan

Region

Japan


Condition

Condition

POEMS syndrome

Classification by specialty

Hematology and clinical oncology Neurology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the efficacy and long-term outcomes of POEMS patients underwent ASCT in Japan

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

OS

Key secondary outcomes

PFS, RR(hematological, clinical), 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

20 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

we perform a multicenter retrospective study assessing the clinical course of patients registered to the Japan Society for Hematopoietic Cell Transplantation (JSHCT) TRUMP database

Key exclusion criteria

none

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chiaki Nakaseko

Organization

Chiba University Hospital

Division name

Dep. of Hematology

Zip code


Address

1-8-1 Inohana, chuo-ku, Chiba City

TEL

+81-43-255-6502

Email

chiaki-nakaseko@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Emiko Sakaida

Organization

Chiba University Hospital

Division name

Dep. of Hematology

Zip code


Address

1-8-1 Inohana, chuo-ku, Chiba City

TEL

+81-43-255-6502

Homepage URL


Email

esakaida@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

Chiba University

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 03 Month 05 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.bbmt.org/article/S1083-8791(18)30042-9/abstract

Number of participants that the trial has enrolled


Results

Between January 2000 and December 2011, 94 patients were registered to the database, male 57 and female 37, with the median age of 52 years (range 28-72).

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 07 Month 05 Day

Date of IRB


Anticipated trial start date

2014 Year 03 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2017 Year 12 Month 01 Day


Other

Other related information

published


Management information

Registered date

2014 Year 03 Month 04 Day

Last modified on

2018 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015561


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name