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Status unknownNCT04747652CRAWFORDUpdated Jul 1, 2021

Clinical Research on Advanced Warning Factors Of Respiratory Injury in Dermatomyositis

An observational study in Dermatomyositis and Respiratory Injury, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-01.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Dermatomyositis
  • Respiratory Injury

Keywords

  • Dermatomyositis
  • Respiratory Injury
  • Advanced Warning
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In context

Dermatomyositis

171 studies on the registry are indexed under Dermatomyositis; 61 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 183 across 40 observational studies indexed under Dermatomyositis.

Browse Dermatomyositis studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Recruit inpatients from department of rheumatology and immunology of eighteen tertiary hospitals in Jiangsu province

Inclusion criteria

  • adult patients meet the diagnostic criteria for dermatomyositis of Bohan and Peter

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. death

    death caused by dermatomyositis and its related complications

    Time frame: within 12 months after disease oneset

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Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital with Nanjing Medical University
    Nanjing, Jiangsu 210029, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04747652
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
National Natural Science Foundation of China
Responsible party
Wenfeng Tan (Chief Physician, The First Affiliated Hospital with Nanjing Medical University) — Principal investigator
First posted
Feb 10, 2021
Start date
Jun 1, 2020
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Jul 1, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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