NCT04707781

Brief Summary

The purpose of this study is to establish a clinical database for patients bearing at risk for ILD (Interstitial Lung Disease) and to set up a prospective ILD Screening program for these patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
412

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started May 2021

Longer than P75 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 Progress65%
May 2021Jan 2029

First Submitted

Initial submission to the registry

January 12, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

7.8 years

First QC Date

January 12, 2021

Last Update Submit

January 13, 2026

Conditions

Lung Diseases, Interstitial

Outcome Measures

Primary Outcomes (1)

  • DLCO%pred (carbon monoxide diffusing capacity) at time of ILD diagnosis

    The investigators aim to assess DLCO% pred at time of ILD diagnosis in patients undergoing a ILD Screening algorithm and compare to the retrospective patient cohort with diagnosed ILD and the DLCO%pred at time of ILD diagnosis

    5 years

Secondary Outcomes (1)

  • FVC%pred (Forced vital capacity) at time of ILD diagnosis

    5 years

Study Arms (2)

prospective patient cohort

patients who will undergo the prospective ILD Screening algorithm

Diagnostic Test: chest CT

retrospective patient cohort

patients with diagnosed ILD

Diagnostic Test: chest CT

Interventions

chest CTDIAGNOSTIC_TEST

assessment of interstitial lung disease using chest CT

prospective patient cohortretrospective patient cohort

Eligibility Criteria

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

Patients (females and males; above 18 yrs) with a known systemic disease bearing a risk for ILD but without diagnosed ILD and patients (females and males; above 18 yrs) with diagnosed ILD.

You may qualify if:

  • Age: ≥ 18 years
  • patients with a known systemic disease bearing a risk for ILD
  • signed informed consent (for prospective part)

You may not qualify if:

  • Age \< 18 years
  • comorbidities severely limiting life-expectancy (e.g. severe cardiovascular conditions, malignant disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz, Department of Internal Medicine, Division of Pulmonology

Graz, 8036, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples of prospectively included patients will be stored in the Biobank Graz

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Central Study Contacts

Gabor Kovacs, MD

CONTACT

+43-316-385gabor.kovacs@klinikum-graz.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 13, 2021

Study Start

May 1, 2021

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

AU(1)