CompletedNot Applicable

Defective FGFR2 Signaling in the Small Airway Basal Progenitor Cells in COPD

United States111 participantsStarted 2014-07

Plain-language summary

Early changes associated with the development of smoking-induced diseases, e.g., COPD and lung cancer (the two commonest causes of death in U.S.) are often characterized by abnormal airway epithelial differentiation. Airway basal cells (BC) are stem/progenitor cells necessary for generation of differentiated airway epithelium. Based on our preliminary observations on SAE BC cells and FGFR2 signaling, we hypothesized that suppression of FGFR2 signaling in the SAE BC stem/progenitor cells by cigarette smoking renders these cells less potent in generating and maintaining normally differentiated SAE, shifting these cells towards a COPD associated phenotype. To test this, SAE basal cells will be isolated from cultured cells obtained through bronchoscopic brushings and analyzed through in vitro assays for their stem/progenitor capacities.

Who can participate

Age range

18 Years

Sex

ALL

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Samples from newly recruited research subjects will be collected under the IRB approved protocol "Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies" (IRB # 1204012331) or may have been collected under previous IRB approved collection protocols: #0005004439, #0005004440, and #0905010391. Inclusion Criteria: * Must be capable of providing informed consent * Males and females, age 18 or older * Nonsmoking, matched with other groups by age, sex, ethnic/racial group * Good overall health without history of chronic lung disease, including asthma, and without recurrent or recent (within 3 months) acute pulmonary disease * Normal physical examination * Normal routine laboratory evaluation, including general hematologic studies, general serologic/ immunologic studies, general biochemical analyses, and urine analysis * Negative HIV serology * Normal chest X-ray (PA and lateral) * Normal electrocardiogram * Females - not pregnant * No history of allergies to medications to be used in the bronchoscopy procedure * Not taking any medications relevant to lung disease or having an effect on the airway epithelium * Willingness to participate in the study Exclusion Criteria: * Unable to meet the inclusion criteria * Pregnancy * Current active infection or acute illness of any kind * Current alcohol or drug abuse * Evidence of malignancy within the past 5 years

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Expression of FGFR2 and related pathways in SAE BC

Timeframe: 5 Years

Trial details

NCT IDNCT02341326

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-10-29

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