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NCT03457935 Clinical Trial

Detection of Early Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:
The Role of the miR200 Family in the Restoration of Normal Lung Homeostasis and Detection of Early IPF

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03457935
Other study ID # 23201
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 10, 2018
Est. completion date December 31, 2024

Study information
Verified date March 2024
Source Temple University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is to determine if miR200 family may serve as a biomarker of IPF.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 450
Est. completion date December 31, 2024
Est. primary completion date March 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria for IPF Patients: - Informed consent - Subjects = 40 y.o. - Naive patients with no IPF treatment - IPF diagnosis based on the ATS/ERS/JRS/ALAT criteria Inclusion Criteria for non-IPF ILD Patients: - Informed consent - Subjects = 18 y.o. - ILD diagnosis Exclusion Criteria: - HIV - Hepatitis B - Hepatitis C - Pregnant or lactating women inclusion criteria for controls: informed consent >18 years old; no lung diseases

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• blood samples
Blood samples

Locations
Country Name City State
United States Temple University Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Temple University Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine miR200 levels (fold change) in blood samples. MicroRNAs (miRs) are noncoding small RNAs, which regulate numerous physiological and pathological processes. miR200 levels will be measured in blood samples collected from control subjects, non-IPF ILD and IPF patients. These samples will be used for identifying biomarkers for IPF. Baseline (one time).
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