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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044082
Receipt No. 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 2021/04/30

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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
Institute Department of Neurology, Graduate School of Medicine, Chiba University
Institute
Department

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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 06 Day
Last follow-up date
2023 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
2021 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.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


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