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Detection of Early Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT03457935
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Temple University

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
Idiopathic Pulmonary Fibrosis Other: blood samples

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Study Type : Observational
Estimated 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 : April 10, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Group/Cohort 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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Controls and subjects with non-IPF ILD and a new diagnosis of IPF.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457935


Contacts
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Contact: Beata Kosmider, MS, PhD 2157079084 beata.kosmider@temple.edu

Locations
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United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Beata Kosmider, MS, PhD    215-707-9084    beata.kosmider@temple.edu   
Sponsors and Collaborators
Temple University
Boehringer Ingelheim

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT03457935     History of Changes
Other Study ID Numbers: 23201
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial