UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014293 |
|---|---|
| Receipt number | R000016191 |
| Scientific Title | Evaluation of Rheumatic disease by Nailfold Videocapillaroscope, flowcytometer, Autoantibody mesurement, Dermatohistopathology |
| Date of disclosure of the study information | 2014/06/17 |
| Last modified on | 2025/12/25 15:25:13 |
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Basic information
Public title
Evaluation of Rheumatic disease by Nailfold Videocapillaroscope, flowcytometer, Autoantibody mesurement, Dermatohistopathology
Acronym
SCOPE study
Scientific Title
Evaluation of Rheumatic disease by Nailfold Videocapillaroscope, flowcytometer, Autoantibody mesurement, Dermatohistopathology
Scientific Title:Acronym
SCOPE study
Region
| Japan |
Condition
Condition
Systemic Sclerosis, polymyositis/dermatomyositis, Mixed Connective Tissue Disease. Systemic lupus erythematosus
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the reliability of the semiquantitative nailfold videocapillaroscopy assessment in rheumatic disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between the semiquantitative nailfold videocapillaroscopy assessment and the severity score of rheumatic disease
Key secondary outcomes
Relationship among the semiquantitative nailfold videocapillaroscopy assessment, the specific autoantibody, the dermatohistopathology, the score of interstitial pneumonia, the pressure of pulmonary artery, and the patients background.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who give a full consent to this study
Key exclusion criteria
Patients who are inadequate by investigator's decision
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshiya |
| Middle name | |
| Last name | Tanaka |
Organization
University of Occupational and Environmental Health, Japan
Division name
The first department of internal medicine, school of medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi, Kitakyushu, Japan
TEL
093-603-1611
tanaka@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiya |
| Middle name | |
| Last name | Tanaka |
Organization
University of Occupational and Environmental Health, Japan
Division name
The first department of internal medicine, school of medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi, Kitakyushu, Japan
TEL
093-603-1611
Homepage URL
tanaka@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Medical Research,University of Occupational and Environmental Health,Japan
Address
1-1 Iseigaoka, Yahatanishiku, Kitakyushu
Tel
093-603-1611
daigakukanri@mbox.pub.uoeh-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
| 2014 | Year | 06 | Month | 17 | 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
| 2014 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of Rheumatic disease by Nailfold Videocapillaroscope, flowcytometer, Autoantibody mesurement, Dermatohistopathology
Management information
Registered date
| 2014 | Year | 06 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016191
