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Clinical Research on Advanced Warning Factors Of Respiratory Injury in Dermatomyositis

Clinical Research on Advanced Warning Factors Of Respiratory Injury in Dermatomyositis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04747652
Acronym
CRAWFORD
Enrollment
1000
Registered
2021-02-10
Start date
2020-06-01
Completion date
2022-12-31
Last updated
2021-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatomyositis, Respiratory Injury

Keywords

Dermatomyositis, Respiratory Injury, Advanced Warning

Brief 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.

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.

Interventions

None listed

Sponsors

National Natural Science Foundation of China
CollaboratorOTHER_GOV
The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
deathwithin 12 months after disease onesetdeath caused by dermatomyositis and its related complications

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026