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Clinical Trial Summary

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04747652
Study type Observational [Patient Registry]
Source The First Affiliated Hospital with Nanjing Medical University
Contact
Status Recruiting
Phase
Start date June 1, 2020
Completion date December 31, 2022

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