UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056377 |
|---|---|
| Receipt number | R000064404 |
| Scientific Title | POEMS (Crow/Fukase) Syndrome Registry (Japan Neuroimmune disease registry) |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/06/20 13:22:39 |
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Basic information
Public title
POEMS Registry for Optimizing Management, Improving Support, and Enhancing care
Acronym
PROMISE
Scientific Title
POEMS (Crow/Fukase) Syndrome Registry (Japan Neuroimmune disease registry)
Scientific Title:Acronym
POEMS syndrome registry
Region
| Japan |
Condition
Condition
Neuroimmune Disease (POEMS(Crow/Fukase) syndrome)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We will clarify the natural history and prognostic factors of POEMS syndrome by accumulating and reviewing clinical information over a long period of time.
Basic objectives2
Others
Basic objectives -Others
We will establish a system to enable efficient recruitment of patients for clinical trials. This will contribute to the development and establishment of new treatment methods for POEMS syndrome in the future.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The course of clinical endpoints mainly used for each neuroimmune disease.
Key secondary outcomes
1. Neurological findings (ONLS, grip strength, MRC sun score, Performance Status)
2. EQ-5D-5L survey
3. Adverse events
4. Blood examination (VEGF)
5. Monoclonal plasma cell proliferation (proved by serum or urine M protein positivity (immunofixation), bone marrow examination, etc.)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with POEMS syndrome who meet probable or higher in the following diagnostic criteria
Major Criteria
(1)Multiple polyneuropathy
(2)Monoclonal plasma cell proliferation (proven by serum or urine M-protein positivity (immunofixation), bone marrow examination, etc.)
(3)Elevated serum VEGF (above 1000 pg/ml)
Sub criteria
(4)Osteosclerotic lesions
(5)Castleman's disease
(6)Organ enlargement (lymph nodes, liver, spleen)
(7)One or more of edema, pleural effusion, ascites, or cardiac effusion
(8)Endocrine abnormalities* (adrenal, thyroid, pituitary, gonad, parathyroid, diabetes)
(9)Skin abnormalities (pigmentation, bristle, hemangioma, cyanosis, canities unguium)
(10)Papillary edema
(11)Platelet hyperplasia
*Note that thyroid function abnormalities and diabetes mellitus are not included in the sub-criteria because of their high prevalence.
Definite: 3 of the major criteria and at least 1 of the sub criteria are met.
Probable: fulfillment of major criteria (1) and (3) and at least one of the sub criteria
2. Patients who have given written consent to participate in the study
Key exclusion criteria
1. Patients deemed inappropriate for inclusion by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sonoko |
| Middle name | |
| Last name | Misawa |
Organization
National University Corporation Chiba University Hospital
Division name
Associate Professor, Department of Neurology
Zip code
2600856
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi Chiba
TEL
0432227171
sonoko.m@nifty.com
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Suichi |
Organization
National University Corporation Chiba University Hospital
Division name
Special Assistant Professor, Department of Neurology
Zip code
2600856
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi Chiba
TEL
0432227171
Homepage URL
t-suichi@plum.ocn.ne.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Personal information, management information, background information, past disease, clinical symptoms, relapse, blood examination, urine examination, corebrospinal fluid findings, nerve conduction tests, details of treatment
Management information
Registered date
| 2024 | Year | 12 | Month | 06 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064404
