NCT03478553

Brief Summary

This study seeks to screen first degree family members of people with Idiopathic Pulmonary Fibrosis (IPF) for the earliest signs of lung fibrosis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jan 2018

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

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Study Timeline

Key milestones and dates

Study Progress95%
Jan 2018Dec 2026

Study Start

First participant enrolled

January 18, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

9 years

First QC Date

March 12, 2018

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Identify and explore genetic loci and related environmental exposures in individuals with familial pulmonary fibrosis and their relatives.

    The investigators aim is to identify and explore genetic loci that affect development of pulmonary fibrosis and also explore related environmental exposures. Idiopathic pulmonary fibrosis (IPF) is one of the interstitial lung diseases under the broader umbrella of idiopathic interstitial pneumonias (IIP). The investigators hypothesize that inherited genetic factors are associated with pulmonary fibrosis.

    Baseline

Study Arms (2)

People with IPF

Other: Blood drawOther: Questionnaire

Family members without IPF

Other: Blood drawOther: Questionnaire

Interventions

Blood draw

Family members without IPFPeople with IPF

Pulmonary Fibrosis Questionnaire

Family members without IPFPeople with IPF

Eligibility Criteria

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

Study population will include up to 20,000 people in the country, both people with IPF and their family members who have never been diagnosed with IPF.

You may qualify if:

  • Age at least 18 years old
  • Family member diagnosed with IPF

You may not qualify if:

  • \- No family member with IPF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples including DNA, RNA, Plasma

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Blood Specimen CollectionSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • David A Schwartz, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 27, 2018

Study Start

January 18, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations