Detection of Early Idiopathic Pulmonary Fibrosis

• Sponsor: Temple University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03457935
• Collaborator: Boehringer Ingelheim (Industry)
• Enrollment: 450
• Location: 1
• Anticipated Duration (Months): 56.7
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Other: blood samples

Study Design

• Study Type: Observational
• Anticipated Enrollment: 450 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Role of the miR200 Family in the Restoration of Normal Lung Homeostasis and Detection of Early IPF
• Actual Study Start Date: Apr 10, 2018
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To determine miR200 levels (fold change) in blood samples. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria for Control Subjects:

• Subjects ≥ 18 y.o.

• No lung diseases

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 for control subjects, IPF and non-IPF ILD patients:

• HIV

• Hepatitis B

• Hepatitis C

• Pregnant or lactating women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Temple University	Philadelphia	Pennsylvania	United States	19140

Sponsors and Collaborators

• Temple University
• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Temple University
• ClinicalTrials.gov Identifier: NCT03457935
• Other Study ID Numbers: 23201
• First Posted: Mar 8, 2018
• Last Update Posted: Nov 9, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis

Study Results

No Results Posted as of Nov 9, 2021