NCT03457935

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Apr 2018Aug 2026

First Submitted

Initial submission to the registry

February 28, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 10, 2018

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

December 29, 2025

Status Verified

September 1, 2025

Enrollment Period

7.7 years

First QC Date

February 28, 2018

Last Update Submit

December 21, 2025

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

  • 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).

Study Arms (3)

Non-IPF ILD

non-IPF ILD diagnosis

Other: blood samples

IPF

Naive patients with no IPF treatment

Other: blood samples

Control

no lung diseases

Other: blood samples

Interventions

blood samplesOTHER

Blood samples

ControlIPFNon-IPF ILD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Informed consent
  • Subjects ≥ 40 y.o.
  • Naive patients with no IPF treatment
  • IPF diagnosis based on the ATS/ERS/JRS/ALAT criteria
  • Informed consent
  • Subjects ≥ 18 y.o.
  • ILD diagnosis

You may not qualify if:

  • HIV
  • Hepatitis B
  • Hepatitis C
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 8, 2018

Study Start

April 10, 2018

Primary Completion

December 31, 2025

Study Completion (Estimated)

August 30, 2026

Last Updated

December 29, 2025

Record last verified: 2025-09

Locations

US(1)