NCT04016181

Brief Summary

To prospectively study novel blood and lung biomarkers of disease activity in patients with IPF and other interstitial lung disease with the aims of prognostic modelling and disease clustering

Trial Health

83
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
129mo left

Started Jun 2007

Longer than P75 for all trials

Status
enrolling by invitation

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 Progress64%
Jun 2007Dec 2036

Study Start

First participant enrolled

June 14, 2007

Completed
11.8 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
9.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2036

Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

19.6 years

First QC Date

March 29, 2019

Last Update Submit

June 23, 2025

Conditions

Idiopathic Pulmonary FibrosisInterstitial Lung DiseaseAsbestosis

Outcome Measures

Primary Outcomes (1)

  • Time to death (all cause)

    Biomarkers that are associated with increased all-cause mortality

    15 years

Secondary Outcomes (3)

  • Rate of decline in vital capacity

    15 years

  • Time to death (lung-related)

    15 years

  • Rate of decline in TLCO

    15 years

Other Outcomes (2)

  • Identification of novel disease clusters

    15 years

  • Time to oxygen prescription

    15 years

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with all entities of interstitial lung disease

You may qualify if:

  • patients with interstitial lung disease attending the Edinburgh Lung Fibrosis service

You may not qualify if:

  • candidates not a suitable for enrolment or unlikely to comply with the requirements of this study, in the opinion of the investigator, will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.

    PMID: 35688625DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum EDTA blood Bronchoalveolar lavage (fluid and cells) Lung biopsy (fresh and formalin fixed)

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisLung Diseases, InterstitialAsbestosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung DiseasesRespiratory Tract DiseasesPneumoconiosisLung InjuryOccupational Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2019

First Posted

July 11, 2019

Study Start

June 14, 2007

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 1, 2036

Last Updated

June 25, 2025

Record last verified: 2025-06