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

NCT06149039 | Unknown

• 1 other identifier: YXH2022ZX03223
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dermatomyositis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• T helper 17 cell

  Th17 cells are an important subset of CD4+T lymphocytes, which can express specific transcription factor RORγT and secrete cytokine IL-17.

  2023-04-01 - 2024-06-30

Study Arms (4)

Nonmyopathic dermatomyositis with interstitial lung disease

Classical dermatomyositis with interstitial lung disease

Rheumatic disease with interstitial lung disease in non-inflammatory myopathy

Healthy adult

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients and healthy adults who meet inclusion criteria

You may qualify if:

• The experimental group met the diagnostic criteria of Sontheimer and was diagnosed as CADM with pulmonary interstitial disease.
• 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;
• 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.
• Age 18-70 years old;
• Have a good understanding of their own illness and physical condition, have self-knowledge, can communicate well with others;
• Voluntarily join the study, understand the significance of the experiment and the indicators to be measured, and sign the informed consent.

You may not qualify if:

• 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);
• Severe cardiovascular disease: including chronic heart dysfunction grade 3 or above and various arrhythmias;
• Infectious diseases: hepatitis active stage, AIDS, syphilis, etc.
• Tumor markers of patients suggest the possibility of tumor.
• Patients with neuromuscular disease, inflammatory bowel disease, functional gastrointestinal disease;
• The patient has other connective tissue diseases or disorders.

Sponsors & Collaborators

• Yanfeng Hou: lead

Study Sites (1)

Yanfeng Hou

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Conditions

Dermatomyositis

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Hou Y feng

CONTACT

15168888165; yfhou1016@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 28, 2023
• Study Start: April 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

CN (1)