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

November 19, 2023 updated by: Yanfeng Hou
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Yanfeng Hou
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients and healthy adults who meet inclusion criteria

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Nonmyopathic dermatomyositis with interstitial lung disease
Classical dermatomyositis with interstitial lung disease
Rheumatic disease with interstitial lung disease in non-inflammatory myopathy
Healthy adult

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
T helper 1 cell
Time Frame: 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.
2023-04-01 - 2024-06-30
T helper 2 cell
Time Frame: 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.
2023-04-01 - 2024-06-30
T helper 17 cell
Time Frame: 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.
2023-04-01 - 2024-06-30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yanfeng Hou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YXH2022ZX03223

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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