UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044082
Receipt number R000050333
Scientific Title Clinical study on serum biomarkers associated with prognosis and pathology of POEMS syndrome
Date of disclosure of the study information 2021/05/01
Last modified on 2023/11/02 18:41:44

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Basic information

Public title

Clinical study on serum biomarkers associated with prognosis and pathology of POEMS syndrome

Acronym

Clinical study on serum biomarkers associated with prognosis and pathology of POEMS syndrome

Scientific Title

Clinical study on serum biomarkers associated with prognosis and pathology of POEMS syndrome

Scientific Title:Acronym

Clinical study on serum biomarkers associated with prognosis and pathology of POEMS syndrome

Region

Japan


Condition

Condition

POEMS syndrome

Classification by specialty

Hematology and clinical oncology Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the association between cytokine profiles/neurofilament light chain and specific organ failure pattern.

Basic objectives2

Others

Basic objectives -Others

To explore the novel treatment target by elucidating the cytokine profile of severe cases.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cytokine
Neurofilament light chain
Clinical symptoms

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Blood test: Cytokine and neurofilament light chain assay

Interventions/Control_2

Blood test: Cytokine and neurofilament light chain assay

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patents with POEMS syndrome
1. 20 years-old or older at the time of obtaining consent
2. Patients with POEMS syndrome who visited Chiba University Hospital after 2000

Healthy volunteers
1. 20 years-old or older at the time of obtaining consent
2. Individuals who have no complications

Key exclusion criteria

Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Kuwabara

Organization

Graduate School of Medicine, Chiba University

Division name

Neurology

Zip code

260-8677

Address

1-8-1, Inohana, Chuo-ku, Chiba

TEL

+81432227171

Email

kuwabara-s@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Tomoki
Middle name
Last name Suichi

Organization

Graduate School of Medicine, Chiba University

Division name

Neurology

Zip code

260-8677

Address

1-8-1, Inohana, Chuo-ku, Chiba

TEL

+81432227171

Homepage URL


Email

t-suichi@plum.ocn.ne.jp


Sponsor or person

Institute

Department of Neurology, Graduate School of Medicine, Chiba University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics committee in Graduate School of Medicine, Chiba University

Address

1-8-1, Inohana, Chuou-ku, Chiba

Tel

+81432227171

Email

inohana-rinri@chiba-u.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



Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 01 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

Open public recruiting

Date of protocol fixation

2021 Year 04 Month 30 Day

Date of IRB

2021 Year 04 Month 28 Day

Anticipated trial start date

2021 Year 05 Month 06 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 04 Month 30 Day

Last modified on

2023 Year 11 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050333


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name