NCT06203249

Brief Summary

The purpose of this study was to analyze the relationship between the microbial community, host immunity and the presence or absence of concurrent rapidly progressive interstitial lung disease patients with anti-MDA5 antibody positive dermatomyositis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jan 2024Nov 2026

First Submitted

Initial submission to the registry

December 28, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

January 20, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2026

Expected
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

December 28, 2023

Last Update Submit

January 10, 2024

Conditions

MicrobiomeImmune FunctionAnti-MDA5 Antibody Positive Dermatomyositis

Outcome Measures

Primary Outcomes (1)

  • The relationship between the microbial community and the presence or absence of interstitial lung disease

    The relationship between the microbial community and the presence or absence of interstitial lung disease

    6 months

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Anti-MDA5 antibody positive dermatomyositis patients with or without interstitial lung disease

You may qualify if:

  • Patients who meet the diagnostic criteria of dermatomyositis and anti-MDA 5 antibody positive.
  • Anti-MDA5 antibody positive DM patients with RPILD meet the diagnostic criteria for RPILD.
  • Must have undergone bronchoalveolar lavage.
  • Age≥18 years old.
  • Patients who signed informed consent forms

You may not qualify if:

  • Patients who had other connective tissue diseases.
  • Patients with ILD or RPILD caused by infection, tumors, drugs, biochemistry and other factors.
  • Pregnant or lactating patients.
  • The patient also participated in any other clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLA

Beijing, Beijing Municipality, 100853, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

bronchoalveolar lavage specimens

Central Study Contacts

Zhimei Duan, doctor

CONTACT

13716376758549117002@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chinese PLA General Hospital

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 12, 2024

Study Start

January 20, 2024

Primary Completion

December 30, 2025

Study Completion (Estimated)

November 25, 2026

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations

CN(1)