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 | 2024/11/01 19:27:13 |
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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
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
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
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
| 2026 | 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
| 2024 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050333
