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

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT03478826

Collaborator

(none)

500

Enrollment

Location

113

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease	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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Jan 1, 2028

Anticipated Study Completion Date :

Jan 1, 2028

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Future Disease Management [1 visit]
Reliable biomarkers to help guide treatment in ILD would be a major step forward in the management of this disease.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Eva M. Carmona Porquera, Assistant Professor of Medicine, College of Medicine, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03478826

Other Study ID Numbers:

17-008088

First Posted:

Mar 27, 2018

Last Update Posted:

Jan 13, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Eva M. Carmona Porquera, Assistant Professor of Medicine, College of Medicine, Mayo Clinic

ILD

Additional relevant MeSH terms:

Lung Diseases

Lung Diseases, Interstitial

Study Results

No Results Posted as of Jan 13, 2022