UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024156 |
|---|---|
| Receipt number | R000027786 |
| Scientific Title | Assessment of the prognosis of the patients of connective tissue disease. |
| Date of disclosure of the study information | 2016/09/26 |
| Last modified on | 2020/03/30 06:22:02 |
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Basic information
Public title
Assessment of the prognosis of the patients of connective tissue disease.
Acronym
Assessment of the prognosis of the patients of connective tissue disease.
Scientific Title
Assessment of the prognosis of the patients of connective tissue disease.
Scientific Title:Acronym
Assessment of the prognosis of the patients of connective tissue disease.
Region
| Japan |
Condition
Condition
rheumatoid arthritis, scleroderma, polymyositis-dermatomyositis, systemic lupus erythematosus, mixed connective tissue disease, Sjogren syndrome, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, microscopic polyangiitis, IgG4-related disease.
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reveal prognostic factor of collagen disease and complications risk factors.
Basic objectives2
Others
Basic objectives -Others
Overall survival
progression-free survival
complications
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
progression-free survival
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet the following of one of the diagnostic criteria.
1) 2010 ACR/EULAR classification criteria for rheumatoid arthritis.
2) 2013 classification criteria for systemic sclerosis
3) Bohan and Peter criteria for polymyositis and dermatomyositis
4) 2012 SLICC classification criteria for systemic lupus erythematosus
5) 2004 Preliminary diagnostic criteria for mixed connective tissue disease proposed by Ministry of Health, Labour and Welfare in Japan.
6) 2012 ACR classification criteria for Sjogren's syndrome
7) 1990 ACR classification of Churg-Strauss syndrome (allergic granulomatosis and angiitis)
8) 1990 ACR classification of Wegener's granulomatosis (granulomatosis and angiitis)
9) 1999 diagnostic criteria for microscopic polyangiitis by Ministry of Health and Welfare in Japan.
10) 2011 Comprehensive diagnostic criteria for IgG4-related disease by Ministry of Health, Labour and Welfare in Japan.
Key exclusion criteria
1) Patients who are judged to be inappropriate as a research subject by the principal investigator or research team members.
2) Patients who are considered to be difficult to obtain a valid consent.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kubo |
| Middle name | |
| Last name | Makoto |
Organization
Yamaguchi University Hospital
Division name
Internal Medicine 2
Zip code
755-8505
Address
1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture,Japan
TEL
0836-22-2248
mkubo@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Kubo |
Organization
Yamaguchi University Hospital
Division name
Internal Medicine 2
Zip code
755-8505
Address
1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture,Japan
TEL
0836-22-2248
Homepage URL
mkubo@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture,Japan
Tel
0836-22-2428
me223@yamaguchi-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
山口大学医学部付属病院(山口県） Yamaguchi University Hospital
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 26 | 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
| 2016 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study is a prospective observational study that does not involve the intervention.
The subjects of the present study are collagen vascular disease patients who meet the selection criteria and are admitted to Yamaguchi University Hospital until December 2019 from September 2016.
Patients are followed for five years and are evaluated a multi-factor analysis including its prognostic factor and risk factor of complications. Analysis items are such as a blood test findings, urinary findings, imaging findings, physiological laboratory findings and biopsy findings. Survival of the subject patients, exacerbation of collagen disease, complications are evaluated after five years of registration.
Management information
Registered date
| 2016 | Year | 09 | Month | 25 | Day |
Last modified on
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027786
| 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 |
