UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053426 |
|---|---|
| Receipt number | R000060975 |
| Scientific Title | VEXAS Syndrome Registry and Repository |
| Date of disclosure of the study information | 2024/01/24 |
| Last modified on | 2024/01/24 15:05:58 |
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Basic information
Public title
VEXAS Syndrome Registry and Repository
Acronym
VEXAS Syndrome Registry and Repository
Scientific Title
VEXAS Syndrome Registry and Repository
Scientific Title:Acronym
VEXAS Syndrome Registry and Repository
Region
| Japan |
Condition
Condition
VEXAS syndrome
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the clinical presentation, natural history, treatment, prognosis, and genotype of VEXAS syndrome.
Basic objectives2
Others
Basic objectives -Others
To elucidate the pathogenesis of VEXAS syndrome.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Life Prognosis of Patients with VEXAS Syndrome
Key secondary outcomes
Symptoms, medications, hospitalization, complications
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
2 points for macrocytic anemia, 1 point for chondritis, 1 point for pulmonary infiltrates, 1 point for skin rash, 1 point for age 50 or older, total of at least 3 points
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Kirino |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-Ku, Yokohama
TEL
+81-45-787-2800
kirino@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Kirino |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-Ku, Yokohama
TEL
+81-45-787-2800
Homepage URL
kirino@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Officer, Yokohama City University
Address
3-9 Fukuura, Kanazawa-Ku, Yokohama
Tel
045-370-7627
rinri@yokohama-cu.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
| 2024 | Year | 01 | Month | 24 | 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
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 09 | 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
Background information: age, gender, height, weight, smoking history, drinking history, medical history, comorbidities, IPSS score
Clinical manifestations of VEXAS syndrome: skin rash, arthritis, lung involvement, chondritis, vasculitis, myelodysplastic syndrome symptoms, eyelid edema, eye
involvement, steroid-resistant inflammation
Treatment of VEXAS syndrome and duration: use of steroids, immunosuppressive drugs, biologics, or other agents
Blood test results: preoperative, postoperative, and at outpatient follow-up: hematology: white blood cell count, neutrophil count, monocyte count, lymphocyte count, MCV, MCHC, RDW, hemoglobin, hematocrit, reticulocyte count, platelets; biochemical tests: total protein, serum albumin, total serum albumin, total serum
Management information
Registered date
| 2024 | Year | 01 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060975
