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

Dermatomyositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06149039
• Other study ID #: YXH2022ZX03223
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Qianfoshan Hospital
• Contact: Hou Y feng
• Phone: 15168888165
• Email: yfhou1016[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To detect the changes of lymphocyte subsets in peripheral blood of non-myopathic dermatomyositis with pulmonary interstitial disease, classical dermatomyositis with pulmonary interstitial disease, rheumatism with non-inflammatory myopathy with pulmonary interstitial disease and healthy adults among the 4 groups, and to detect the related cytokines secreted by lymphocyte subsets Th1,Th2 and Th17. Clinical features, distribution of peripheral lymphocyte subsets ratio and related cytokine content secreted by each lymphocyte subset were analyzed in each group, so as to explore the pathogenesis characteristics of nonmyopathic dermatomyositis complicated with pulmonary interstitial disease, in order to facilitate clinical guidance for diagnosis and treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatomyositis

Locations

Country	Name	City	State
China	Yanfeng Hou	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yanfeng Hou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T helper 1 cell	Th1 cells are a type of lymphocytes that can produce pro-inflammatory cytokines to support the body's immune response.	2023-04-01 - 2024-06-30
Primary	T helper 2 cell	Th2 is a T cell subset that can secrete Th2 type cytokines (such as interleukin IL-4, IL-5, IL-10 and IL-13, etc.), belonging to CD4+T cells.	2023-04-01 - 2024-06-30
Primary	T helper 17 cell	Th17 cells are an important subset of CD4+T lymphocytes, which can express specific transcription factor ROR?T and secrete cytokine IL-17.	2023-04-01 - 2024-06-30