Idiopathic Pulmonary FibrosisNCT02187393
Determining in Vitro Properties of Epithelial Cells From Individuals With Genetic Variants Associated With Idiopathic Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis and Healthy, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Healthy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: normal healthy volunteers
Who may be able to join
- Age greater than 18 years of age
- Ability to provide informed consent
- Patent bilateral nares
Who cannot join
- Significant nasal or sinus disease precluding nasal brushing
- A history of or ongoing epistaxis (nose-bleeding)
- Acute upper respiratory illness
- Ongoing treatment of respiratory or sinus illness with antibiotics
- Pregnancy
- Age less than 18 years
Show all 13Show fewer
- Infection with human immunodeficiency virus (HIV) or viral hepatitides (Hepatitis B, Hepatitis C)
- Prior volunteer for the same study
- Known diagnosis of cystic fibrosis or other ciliary disorder (example: primary ciliar dyskinesia)
- 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)
- Known thrombocytopenia (example: immune thrombocytopenic purpura)
- Ongoing chemotherapy
- Known platelet dysfunction or bleeding diathesis/hemophilia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
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.
- Conditions
- Idiopathic Pulmonary Fibrosis, Healthy
- Keywords
- Epithelial cell function of cells from individuals with various genotypes
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
in vitro epithelial integrity measured by transepithelial electrical resistance (TEER), reported in ohms
The in vitro epithelial cell culture process will take approximately 4-6 weeks after the cells collected are thawed. (At the time of collection from study subjects, cells will be frozen until the time of thawing and culturing.) The in vitro epithelial process will take 6 weeks to differentiate epithelial monolayers at which time the tests of epithelial integrity can be performed. Study subjects themselves are not being followed.
Measured: 6 weeks
Secondary outcomes (1)
gene expression (DSP, MUC5B, genes associated with ER Stress), reported as "fold-change" or "CT mean"
Gene expression assays (designed by Taqman/Life Technologies) will be used to examine expression of genes that we believe are associated with pulmonary fibrosis -- specifically, various mucins (MUC5B, MUC5AC, DSP, and numerous genes associated with endoplasmic reticulum (ER) stress). This will be measured on epithelial monolayers derived in vitro from cells collected from study subjects. The differentiation of epithelial monolayers can take 3-6 weeks depending on the vagaries of the cell culture technique.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJul 2015
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Technical difficulties with the wet bench side of proposed studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- David A Schwartz, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187393
- Sponsor's protocol ID
- 13-3027
- Other IDs
- R01HL097163
- Status last verified
- Nov 2015
- First submitted
- 13 Mar 2014
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining in Vitro Properties of Epithelial Cells From Individuals With Genetic Variants Associated With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02187393
- Acronym / sponsor ID
- 13-3027
- Conditions
- Idiopathic Pulmonary Fibrosis, Healthy
- Keywords
- Epithelial cell function of cells from individuals with various genotypes
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Technical difficulties with the wet bench side of proposed studies.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- normal healthy volunteers
Key inclusion criteria (3 listed)
- Age greater than 18 years of age
- Ability to provide informed consent
- Patent bilateral nares
Key exclusion criteria (13 listed)
- Significant nasal or sinus disease precluding nasal brushing
- A history of or ongoing epistaxis (nose-bleeding)
- Acute upper respiratory illness
- Ongoing treatment of respiratory or sinus illness with antibiotics
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
in vitro epithelial integrity measured by transepithelial electrical resistance (TEER), reported in ohms
Time frame: 6 weeks
The in vitro epithelial cell culture process will take approximately 4-6 weeks after the cells collected are thawed. (At the time of collection from study subjects, cells will be frozen until the time of thawing and culturing.) The in vitro epithelial process will take 6 weeks to differentiate epithelial monolayers at which time the tests of epithelial integrity can be performed. Study subjects themselves are not being followed.
1 secondary outcome
gene expression (DSP, MUC5B, genes associated with ER Stress), reported as "fold-change" or "CT mean"
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Schwartz, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis and Healthy, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in vitro epithelial integrity measured by transepithelial electrical resistance (TEER), reported in ohms (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2015.