UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036790 |
|---|---|
| Receipt number | R000041922 |
| Scientific Title | Analysis of the mechanism for anti-RNP antibodies in systemic autoimmune diseases |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2020/12/07 10:14:34 |
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Basic information
Public title
Analysis of the mechanism for anti-RNP antibodies in autoimmune diseases
Acronym
Analysis of the mechanism for anti-RNP antibodies
Scientific Title
Analysis of the mechanism for anti-RNP antibodies in systemic autoimmune diseases
Scientific Title:Acronym
Analysis of the mechanism for anti-RNP antibodies
Region
| Japan |
Condition
Condition
systemic lupus erythematosus, mixed connective tissue disease, systemic sclerosis, rheumatoid arthritis, vasculitis syndrome, drug-induced lupus erytnematosus, healthy condition
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find aberrant protein expression and post-translational modification of autoantigens in anti-RNP antibody- and the other autoantibody-positive patients and patients-with drug-induced lupus erythematosus
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Levels and post-translational modifications of U1-68k
Key secondary outcomes
Change of protein expression and post-translational modification by drugs
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
Patients who have been diagnosed or suspected having the target diseases in St. Marianna University hospital. Healthy individuals who visit St. Marianna University hospital (i.e., for medical check). Healthy individuals who work in St. Marianna University and St. Marianna University hospital.
Key exclusion criteria
Patients who are excluded from the entry by medical doctors (i.e., severe or moderate levels of anemia)
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Manae |
| Middle name | Suzuki |
| Last name | Kurokawa |
Organization
St. Marianna University Graduate School of Medicice
Division name
Disease Biomarker Analysis and Molecular Regulation
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL
81-44-977-8111
manae@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Manae |
| Middle name | Suzuki |
| Last name | Kurokawa |
Organization
St. Marianna University Graduate School of Medicice
Division name
Disease Biomarker Analysis and Molecular Regulation
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL
81-44-977-8111
Homepage URL
manae@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki
Tel
81-44-977-8111
k-sienbu.mail@marianna-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
| 2019 | Year | 06 | 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
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | 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
We are analyzing levels and post-translational modifications of U1-68k in peripheral lymphocytes from the patients with target diseases and healthy individuals.
Management information
Registered date
| 2019 | Year | 05 | Month | 18 | Day |
Last modified on
| 2020 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041922
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
