Advancing Prevention of Pulmonary Fibrosis | NCT04564183

Studies
Advancing Prevention of Pulmonary Fibrosis

NCT04564183

Sponsor

University of Colorado, Denver

Status

Active, not recruiting

Last Update Posted

Mar 25, 2025Actual

Enrollment

800Estimated

Phase

Not provided

Conditions

IPF
Pulmonary Fibrosis
ILD

Interventions

Sample collection
Questionnaires
High resolution CT scan of the chest
Pulmonary Function Test

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

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 22, 2021Actual

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Aug 1, 2026Estimated

First Submitted Date

Sep 18, 2020

First Submission Date that Met QC Criteria

Sep 21, 2020

First Posted Date

Sep 25, 2020Actual

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

Name	Class
Mayo Clinic	OTHER
University of California, Los Angeles	OTHER
University of Texas	OTHER
University of Pennsylvania

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 study plans to learn more about pulmonary fibrosis and how it develops. We want to determine if the disease can be detected early, before the lung is permanently scarred.

This study will enroll participants who are not currently diagnosed with pulmonary fibrosis, but who have family members with pulmonary fibrosis. Because there is an increased risk within affected families, this cohort will allow us to learn how pulmonary fibrosis develops, and how the lungs change over time.

Detailed Description

Not provided

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

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Full Cohort		Entire study population	Other: Sample collection Other: Questionnaires Radiation: High resolution CT scan of the chest Diagnostic Test: Pulmonary Function Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sample collection	Other	Blood, Urine, Nail, Hair, Saliva, optional Stool	Full Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Screen all subjects for early Idiopathic Pulmonary Fibrosis (IPF) with High Resolution CT Scan of the Chest	All subjects will be screened with a high resolution CT scan to identify early signs of lung fibrosis. CT scans will be evaluated by study radiologists.	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unaffected first degree relative from Familial Interstitial Pneumonia families (two or more family members with IIP)
Age at least 40 years old and younger than 75 years old

Exclusion Criteria:

Diagnosed with known (physician-diagnosed) pulmonary fibrosis prior to informed consent
Other genetic diseases associated with interstitial lung disease
Pregnant women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

We will enroll up to 1,000 participants who are in families with two or more reported cases of pulmonary fibrosis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Schwartz, MD	University of Colorado School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Anschutz Medical Campus		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
D011658	Pulmonary Fibrosis

Ancestor Terms

ID	Term
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D005355	Fibrosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013048	Specimen Handling
D011795	Surveys and Questionnaires
D012129	Respiratory Function Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided