Creation of a Biospecimen Repository From Patients With Interstitial Lung Diseases (ILD)

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.

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Other: ILD; Other: Healthy; Other: Pneumonia

Detailed Description

The proposed biospecimen repository would be derived from patients diagnosed with ILD. This is to include 500 patients in the repository, with each patient contributing one blood sample. Patients with pneumonia and healthy patients will also be recruited as a control group.

• Study Type: Observational
• Enrollment (Estimated): 635

Contacts and Locations

• Study Contact: Name: Michael Stachowitz; Phone Number: 507-284-4862; Email: Stachowitz.Michael@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Eva Carmona, M.D., Ph.D.
      • Contact: Michael Stachowitz; Phone Number: 507-284-4862; Email: Stachowitz.Michael@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Unwillingness/unable to give blood samples

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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
Healthy; 100 healthy participants as a control group.	Other: Healthy; 100 cc of blood collected from a total of 25 healthy volunteers in order to compare with the ILD participants.
Pneumonia; 25 patients with pneumonia as a control group.	Other: Pneumonia; 100 cc of blood collected from a total of 100 participants with a diagnosis of pneumonia in order to compare with the ILD participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Eva M Carmona Porquera, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: ILD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 17-008088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No