Clinical trial NCT02187393: Determining in Vitro Properties of Epithelial Cells From Individuals With Genetic Variants Associated With Idiopathic Pulmonary Fibrosis
Official title: Determining in Vitro Properties of Epithelial Cells From Individuals With Genetic Variants Associated With Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Idiopathic Pulmonary Fibrosis
Healthy
Keywords: Epithelial cell function of cells from individuals with various genotypes
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: normal healthy volunteers

Brief summary: The investigators are trying to understand the role of specific genes in the function of airway surface cells. The investigators know that there are some common genetic markers that are associated with various lung diseases. However, most people with these genetic markers never develop any evidence of lung disease, so it is not understand how or if these markers play a role in disease. Investigators are asking healthy people to provide three (3) tubes of blood as well as a sample of cells from their nose. Investigators will use the blood sample to provide genetic information (specifically, presence or absence of alleles known to be associated with pulmonary fibrosis). Nose cells from individuals with the genetic markers that investigators are studying will be grown in the the lab to allow investigators to learn more about how the cells respond to various forms of environmental stress, such as exposure to cigarette smoke. The goal of this study is to understand how specific genes affect airway cell function.


Eligibility criteria: Inclusion Criteria:

1. Age greater than 18 years of age
2. Ability to provide informed consent
3. Patent bilateral nares

Exclusion Criteria:

1. Significant nasal or sinus disease precluding nasal brushing
2. A history of or ongoing epistaxis (nose-bleeding)
3. Acute upper respiratory illness
4. Ongoing treatment of respiratory or sinus illness with antibiotics
5. Pregnancy
6. Age less than 18 years
7. Infection with human immunodeficiency virus (HIV) or viral hepatitides (Hepatitis B, Hepatitis C)
8. Prior volunteer for the same study
9. Known diagnosis of cystic fibrosis or other ciliary disorder (example: primary ciliar dyskinesia)
10. Treatment with anticoagulants (examples: warfarin/coumadin, low molecular weight heparins, direct thrombin inhibitors such as dabigatran, anti-platelet agents such as P2Y12 inhibitors like clopidogrel and prasugrel, aspirin, ticagrelor, or factor Xa inhibitors such as rivaroxaban)
11. Known thrombocytopenia (example: immune thrombocytopenic purpura)
12. Ongoing chemotherapy
13. Known platelet dysfunction or bleeding diathesis/hemophilia

Primary outcomes:
measure: in vitro epithelial integrity measured by transepithelial electrical resistance (TEER), reported in ohms
timeFrame: 6 weeks
Secondary outcomes:
measure: gene expression (DSP, MUC5B, genes associated with ER Stress), reported as "fold-change" or "CT mean"
timeFrame: 6 weeks
Other outcomes:
measure: Epithelial monolayer permeability (protein and cell permeability)
timeFrame: 6 weeks.
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: David A Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References: