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

Sponsor
Yanfeng Hou (Other)
Overall Status
Recruiting
CT.gov ID
NCT06149039
Collaborator
(none)
120
1
15
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study on Lymphocyte Subsets of Peripheral Blood in Patients With Nonmyopathic Dermatomyositis Complicated With Pulmonary Interstitial Disease
    Actual Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Jun 30, 2024
    Anticipated Study Completion Date :
    Jun 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Nonmyopathic dermatomyositis with interstitial lung disease

    Classical dermatomyositis with interstitial lung disease

    Rheumatic disease with interstitial lung disease in non-inflammatory myopathy

    Healthy adult

    Outcome Measures

    Primary Outcome Measures

    1. T helper 1 cell [2023-04-01 - 2024-06-30]

      Th1 cells are a type of lymphocytes that can produce pro-inflammatory cytokines to support the body's immune response.

    2. T helper 2 cell [2023-04-01 - 2024-06-30]

      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.

    3. T helper 17 cell [2023-04-01 - 2024-06-30]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yanfeng Hou Jinan Shandong China 250000

    Sponsors and Collaborators

    • Yanfeng Hou

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yanfeng Hou, professor, Qianfoshan Hospital
    ClinicalTrials.gov Identifier:
    NCT06149039
    Other Study ID Numbers:
    • YXH2022ZX03223
    First Posted:
    Nov 28, 2023
    Last Update Posted:
    Nov 28, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 28, 2023