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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03478826
Other study ID # 17-008088
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date January 2028

Study information

Verified date March 2024
Source Mayo Clinic
Contact Michael Stachowitz
Phone 507-284-4862
Email Stachowitz.Michael@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 635
Est. completion date January 2028
Est. primary completion date January 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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