UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007043 |
|---|---|
| Receipt number | R000008278 |
| Scientific Title | Prospective study of circulating microRNAs for the prediction of the onset of rheumatoid arthritis |
| Date of disclosure of the study information | 2012/01/16 |
| Last modified on | 2014/01/24 16:00:11 |
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Basic information
Public title
Prospective study of circulating microRNAs for the prediction of the onset of rheumatoid arthritis
Acronym
Prediction study of circulating miRNAs for RA onset
Scientific Title
Prospective study of circulating microRNAs for the prediction of the onset of rheumatoid arthritis
Scientific Title:Acronym
Prediction study of circulating miRNAs for RA onset
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether circulating microRNAs can predict the onset of rheumatoid arthritis.
Basic objectives2
Others
Basic objectives -Others
Possibility as clinical biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Fulfillment of 1987 ACR revised criteria for the classification of RA or the 2010 ACR/EULAR classification criteria for RA
Key secondary outcomes
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
| 16 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with undifferentiated arthritis for more than one week.
Key exclusion criteria
Patients who were previously diagnosed as rheumatoid arthritis.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromu Ito |
Organization
Kyoto Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan.
TEL
075-751-3652
hiromu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromu Ito |
Organization
Kyoto Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan.
TEL
075-751-3652
Homepage URL
hiromu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 01 | Month | 16 | 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
| 2011 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The correlation of initial circulating microRNA level with the onset of rheumatoid arthritis during three years is analyzed.
Management information
Registered date
| 2012 | Year | 01 | Month | 10 | Day |
Last modified on
| 2014 | 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=R000008278
