Examining blood lymphocyte changes in patients with dermatomyositis and lung disease

Study on Lymphocyte Subsets of Peripheral Blood in Patients With Nonmyopathic Dermatomyositis Complicated With Pulmonary Interstitial Disease

This study looks at how certain immune cells in the blood change in people with dermatomyositis and lung disease compared to healthy adults to help improve understanding and treatment of these conditions.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Qianfoshan Hospital (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06149039 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze the changes in lymphocyte subsets in the peripheral blood of patients with non-myopathic dermatomyositis complicated by pulmonary interstitial disease, as well as in patients with classical dermatomyositis and rheumatism with non-inflammatory myopathy. The study will compare these groups to healthy adults, focusing on the distribution of lymphocyte subsets and the cytokines they secrete, specifically Th1, Th2, and Th17. By understanding these changes, the study seeks to explore the pathogenesis of the condition and provide clinical guidance for diagnosis and treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-70 diagnosed with non-myopathic dermatomyositis complicated by pulmonary interstitial disease or related conditions.

Not a fit: Patients outside the age range of 18-70 or those without the specified diagnoses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of dermatomyositis and improve diagnostic and treatment strategies for patients with this condition.

How similar studies have performed: While similar studies have explored lymphocyte subsets in autoimmune diseases, this specific focus on non-myopathic dermatomyositis with pulmonary interstitial disease is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. The experimental group met the diagnostic criteria of Sontheimer and was diagnosed as CADM with pulmonary interstitial disease.
2. Control group 1: The diagnosis was consistent with the diagnostic criteria of Bohan and Perter classification system, and it was confirmed that dermatomyositis was combined with pulmonary interstitial disease;
3. Control group 2: The diagnosis meets the classification criteria of systemic lupus erythematosus revised by the American College of Rheumatology (ACR) in 1997 and is confirmed as systemic lupus erythematosus combined with pulmonary interstitial disease, or the diagnosis meets the diagnostic criteria of rheumatoid arthritis introduced by ACR in 1987 or ACR in 2010 and is confirmed as rheumatoid arthritis combined with pulmonary interstitial disease.
4. Age 18-70 years old;
5. Have a good understanding of their own illness and physical condition, have self-knowledge, can communicate well with others;
6. Voluntarily join the study, understand the significance of the experiment and the indicators to be measured, and sign the informed consent.

Exclusion Criteria:

1. Severe infection: fever, cough, phlegm, sore throat, abdominal pain, diarrhea, carbuncle and other skin and soft tissue infection and other clinical manifestations, blood routine white blood cell count beyond the normal range (10×109/L);
2. Severe cardiovascular disease: including chronic heart dysfunction grade 3 or above and various arrhythmias;
3. Infectious diseases: hepatitis active stage, AIDS, syphilis, etc.
4. Tumor markers of patients suggest the possibility of tumor.
5. Patients with neuromuscular disease, inflammatory bowel disease, functional gastrointestinal disease;
6. The patient has other connective tissue diseases or disorders.

Where this trial is running

Jinan, Shandong

• Yanfeng Hou — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Hou Y feng

Conditions Dermatomyositis