Microecology and Immunity in Patients With Anti-MDA5 Anti... | NCT06203249

Studies
Microecology and Immunity in Patients With Anti-MDA5 Antibody Positive Dermatomyositis and Interstitial Lung Disease

NCT06203249

Sponsor

Chinese PLA General Hospital

Status

Recruiting

Last Update Posted

Jan 12, 2024Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Microbiome
Immune Function
Anti-MDA5 Antibody Positive Dermatomyositis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2024Estimated

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Nov 25, 2026Estimated

First Submitted Date

Dec 28, 2023

First Submission Date that Met QC Criteria

Jan 10, 2024

First Posted Date

Jan 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2024

Last Update Posted Date

Jan 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Methods: Bronchoalveolar lavage specimens of patients with anti-MDA5 antibody positive dermatomyositis and interstitial lung disease were collected and studied to analyze the relationship between the composition of patients' microecology and the occurrence and development of disease.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
Disagreement for inclusion in this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhimei Duan, doctor	Contact	13716376758		549117002@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PLA	Recruiting	Beijing	Beijing Municipality	100853	China