Detection of Early Idiopathic Pulmonary Fibrosis

March 20, 2024 updated by: Temple University

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects with non-IPF ILD and a new diagnosis of IPF.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-IPF ILD
non-IPF ILD diagnosis
Other: blood samples
Blood samples
IPF
Naive patients with no IPF treatment
Other: blood samples
Blood samples
Control
no lung diseases
Other: blood samples
Blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine miR200 levels (fold change) in blood samples.
Time Frame: Baseline (one time).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2018

Primary Completion (Actual)

March 15, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 6, 2018

First Posted (Actual)

March 8, 2018

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Idiopathic Pulmonary Fibrosis

Clinical Trials on blood samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe