NCT03478826

Brief Summary

To develop a repository of blood samples from patients with ILD to support future studies into the development of such biomarkers. Patients with pneumonia and healthy patients will also be recruited as a control group.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
635

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Aug 2018Jan 2028

First Submitted

Initial submission to the registry

March 23, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

9.4 years

First QC Date

March 23, 2018

Last Update Submit

April 24, 2026

Conditions

Keywords

ILD

Outcome Measures

Primary Outcomes (1)

  • Future Disease Management

    Reliable biomarkers to help guide treatment in ILD would be a major step forward in the management of this disease.

    1 visit

Study Arms (3)

ILD

250 patients (male and females \>18 years of age) with the diagnosis of fibrotic DILD (IPF (n=100), fibrotic NSIP (n=50), chronic hypersensitivity pneumonia (n=20), sarcoidosis(n=50), progressive rheumatoid lung disease (n=10) and scleroderma lung disease (n=20), 10 patients with other fibrosing disease (fibrosing mediastinitis), and 50 patients with lymphangioleiomyomatosis.

Other: ILD

Healthy

100 healthy participants as a control group.

Other: Healthy

Pneumonia

25 patients with pneumonia as a control group.

Other: Pneumonia

Interventions

ILDOTHER

100 cc of blood collected from a total of 250 ILD patients. This includes IPF (n=100), fibrotic NSIP (n=50), chronic hypersensitivity pneumonia (n=20), sarcoidosis(n=50), progressive rheumatoid lung disease (n=10) and scleroderma lung disease (n=20)), 10 patients with other fibrosing disease (fibrosing mediastinitis), and 50 patients with lymphangioleiomyomatosis

ILD
HealthyOTHER

100 cc of blood collected from a total of 25 healthy volunteers in order to compare with the ILD participants.

Healthy

100 cc of blood collected from a total of 100 participants with a diagnosis of pneumonia in order to compare with the ILD participants.

Pneumonia

Eligibility Criteria

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

Patients with a diagnosis of ILD or any fibrotic disease of the lung. A diagnosis of pneumonia and healthy volunteers will also be included as a control group.

You may qualify if:

  • Patients with a diagnosis of ILD or any fibrotic disease of the lung or a diagnosis of pneumonia
  • Patients willing to provide written informed consent

You may not qualify if:

  • Unwillingness/unable to give blood samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

To develop a repository of blood samples from patients with ILD to support future studies into the development of such biomarkers. Patients with pneumonia and healthy patients will also be recruited as a control group. The repository would be maintained in Dr. Carmona's laboratory in the Thoracic Diseases Research Unit in the Stabile building where all biospecimens will be stored. These samples will be stored in freezers in Dr. Carmona's laboratory space in the Thoracic Diseases Research Unit in the Stabile building for future research.

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Eva M Carmona Porquera, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, College of Medicine

Study Record Dates

First Submitted

March 23, 2018

First Posted

March 27, 2018

Study Start

August 1, 2018

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

IPD will not be shared at this time, but it may be possible that in the future outside institutions or other researchers within the Mayo Clinic may ask for specimen samples. If a specimen sample is requested, a new protocol will be submitted to the IRB or the IRB application for this study will be amended.

Locations