- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04747652
Clinical Research on Advanced Warning Factors Of Respiratory Injury in Dermatomyositis (CRAWFORD)
Study Overview
Status
Conditions
Detailed Description
Dermatomyositis (DM) is a highly heterogeneous autoimmune disease characterized by rash and myasthenia. Beside these, respiratory involvement is one of the common complications of DM. Interstitial lung disease (ILD) occur in approximately 90% of patients with DM, part of them may manifest rapidly progressive-interstitial lung disease (rp-ILD), which progresses into respiratory failure that is difficult to correct and leads to death. Early identification of rp-ILD high risk group is of great significance to improve the prognosis of patients and to conduct following clinical studies. A simple, easy, convenient and reliable diagnostic tool has not yet acquired till now.
MSG-Jiangsu, short for Myositis Study Group-Jiangsu, was founded by department of rheumatology and immunology of eighteen tertiary hospitals. Clinical Research on Advanced Warning Factors Of Respiratory Injury in Dermatomyositis (CRAWFORD) as a multicenter observational cohort study was started at Jun 1, 2020. Our cohort plan to recruit 1,000 adult inpatients. What's more, prognostic data from these DM patients were obtained by following up for 1 year. At the same time, clinical data and auxiliary examination results of the baseline DM patients were analyzed to look for factors that are associated with outcomes. Then, regression analysis of influencing factors will help us to set up a multi-factor weighted score to forecast the prognosis of DM patients. Finally, Biological specimen from patients at baseline are used to look for biomarkers that predict prognosis by RNA-sequencing, whole exon sequencing, proteomic screening and so on.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- Recruiting
- The First Affiliated Hospital with Nanjing Medical University
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Contact:
- Wenfeng Tan, PhD, MD
- Phone Number: 086 18061202878
- Email: tanwenfeng@jsph.org.cn
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Contact:
- Lingxiao Xu, PhD, MD
- Phone Number: 086 18020130778
- Email: lingxiao32@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult patients meet the diagnostic criteria for dermatomyositis of Bohan and Peter
Exclusion Criteria:
- complicated with other connective tissue diseases
- complicated with cardiovascular and respiratory disease caused by other reasons
- interstitial lung disease caused by environment and drugs
- patients with key research missing data or without informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
death
Time Frame: within 12 months after disease oneset
|
death caused by dermatomyositis and its related complications
|
within 12 months after disease oneset
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSG-jiangsu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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