The Genetics of Pulmonary Fibrosis | NCT03478553

Studies
The Genetics of Pulmonary Fibrosis

NCT03478553

Sponsor

University of Colorado, Denver

Status

Recruiting

Last Update Posted

Mar 25, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Interventions

Blood draw
Questionnaire

Countries

United States

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

ID	Type	Description	Link
W81XWH-17-1-0597_1a	Other Grant/Funding Number	Department of Defense

Status Module

Record Verification Date

Mar 2025

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 18, 2018Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 12, 2018

First Submission Date that Met QC Criteria

Mar 20, 2018

First Posted Date

Mar 27, 2018Actual

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

Mar 24, 2025

Last Update Posted Date

Mar 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Detailed Description

The purpose of this study is to explore genetic factors associated with the development of pulmonary fibrosis. 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. To investigate the genetics of pulmonary fibrosis, the investigators plan to enroll individuals with pulmonary fibrosis and their family members.

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
People with IPF			Other: Blood draw Other: Questionnaire
Family members without IPF			Other: Blood draw Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood draw	Other	Blood draw	Family members without IPF People with IPF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age at least 18 years old
Family member diagnosed with IPF

Exclusion Criteria:

- No family member with IPF

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rachel Warren	Contact	303-724-8569		rachel.warren@cuanschutz.edu

Overall Officials

Name	Affiliation	Role
David A Schwartz, MD	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Anschutz Medical Campus	Recruiting	Aurora	Colorado	80045	United States

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

Condition Browse Module

MeSH Terms

ID	Term
D054990	Idiopathic Pulmonary Fibrosis

Ancestor Terms

ID	Term
D011658	Pulmonary Fibrosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided