Interstitial Lung Disease Associated | NCT06007040

Studies
Interstitial Lung Disease Associated

NCT06007040

Sponsor

Peking Union Medical College Hospital

Status

Completed

Last Update Posted

Aug 23, 2023Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Interstitial Lung Disease

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012Actual

Primary Completion Date

Dec 2021Actual

Completion Date

Dec 2021Actual

First Submitted Date

Aug 17, 2023

First Submission Date that Met QC Criteria

Aug 17, 2023

First Posted Date

Aug 23, 2023Actual

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

Aug 17, 2023

Last Update Posted Date

Aug 23, 2023Actual

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

This single-center, retrospective cohort study was conducted to determine whether ANCA-ILD spectrum share the same clinical manifestations and outcome with CTD feature disease spectrum.

Detailed Description

We retrospectively reviewed patients who had been diagnosed with interstitial pneumonia during outpatient or hospitalization at Peking Union Medical College Hospital (PUMCH) between January 2012 and December 2021.

Baseline data collection:
1. Baseline information at the time of initial diagnosis was obtained, and the following items were analyzed: demographic information (age, gender), clinical course, clinical symptoms and signs, laboratory findings [routine blood, erythrocyte sedimentation rate (ESR), hypersensitivity C-reactive protein (Hs-CRP), rheumatoid factor (RF) and serologic autoantibodies], pulmonary function tests (PFTs), and chest HRCT scans.
2. MPO-ANCA and PR3-ANCA titers were measured by ELISA.
3. Chest HRCT images were evaluated by at least two pulmonologists and radiologists. The HRCT scans were analyzed for the following characteristics: ground-glass opacities, reticular patterns, honeycombing, traction bronchiectasis.
4. Spirometry was performed according to standardized guidelines. PFTs results were expressed as percentages of the predicted values, thereby correcting for age, gender and bodyweight.
Treatment was defined as the use of corticosteroids ≥ 10mg/d, azathioprine, cyclophosphamide, mycophenolate mofetil, methotrexate, or rituximab. Follow-up was up to the time of patient's last visit or time of death, and the outcomes were defined as death from all causes.
Outcome

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

No data available

No data is available for this block.

Enrollment

1,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality	death from all causes	From baseline until the date of death from all cause, up to 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females
Aged from 18 to 85 years with informed consent
Have a diagnosis of ILD based on clinical symptoms and radiologic features, with or without histopathologic results

Exclusion Criteria:

ILD induced by drug, environment, or occupational exposure
Hypersensitivity pneumonitis and sarcoidosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Interstitial pneumonia based on clinical symptoms and radiologic features, with or without histopathologic results.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juhong Shi, M.D	Peking Union Medical College Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital		Beijing	Beijing Municipality	100730	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jan 12, 2025
Reset	Feb 6, 2025

Submission Tracking

Estimated Results First Submitted Date

Jan 12, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 12, 2025			Feb 6, 2025

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

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Browse Branches

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