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

NCT ID: NCT06149039

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dermatomyositis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nonmyopathic dermatomyositis with interstitial lung disease

No interventions assigned to this group

Classical dermatomyositis with interstitial lung disease

No interventions assigned to this group

Rheumatic disease with interstitial lung disease in non-inflammatory myopathy

No interventions assigned to this group

Healthy adult

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yanfeng Hou

OTHER

Sponsor Role lead

Responsible Party

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Yanfeng Hou

professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Yanfeng Hou

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hou Y feng

Role: CONTACT

[email protected]
15168888165

Facility Contacts

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Yanfeng Hou, Dr.

Role: primary

[email protected]
15168888165

Other Identifiers

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YXH2022ZX03223

Identifier Type: -

Identifier Source: org_study_id