Role of Genetic Factors in the Development of Lung Disease
Recruiting · Bethesda, Maryland
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Study care at no cost to you
For your time and travel
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Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
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Your choice
Voluntary — you can stop anytime
What is this study?
This study is designed to evaluate the genetics involved in the development of lung disease by surveying genes involved in the process of breathing and examining the genes in lung cells of patients with lung disease. The study will focus on defining the distribution of abnormal genes responsible for processes directly involved in different diseases affecting the lungs of patients and healthy volunteers.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
This study is designed to evaluate the genetics involved in the development of lung disease by surveying genes involved in the process of breathing and examining the genes in lung cells of patients with lung disease. The study will focus on defining the distribution of abnormal genes responsible for processes directly involved in different diseases affecting the lungs of patients and healthy volunteers. Optional CT Sub-study The standard CT scan will be compared to the low dose radiation CT scan for the 150 subjects enrolled in the sub-study to assess the variation between the two techniques. Specifically, the quantitative computer aided detection of lung CT abnormalities from LAM can be compared to assess whether low radiation dose CT exams is an alternative to conventional CT to monitor disease status. This optional sub-study will be offered to up to 100 adult subjects with lung disease and up to 50 children age 9 and older with CF. Children will not be enrolled in the optional CT sub-study unless they have had a standard CT scan for medical purposes to use in comparison. One additional low dose radiation CT scan of the chest may be done as part of this sub-study when these subjects have their next annual CT scan.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults and older teens (age rules depend on the type of lung condition and the site’s approvals) can join if their lung symptoms, chest X-ray, and breathing tests match a lung disease described in the protocol.
- •People with AAT deficiency must have a confirmed AAT diagnosis with a high-risk phenotype, plus lung symptoms and lung test results.
- •People with chronic obstructive pulmonary disease (COPD) must have symptoms, chest X-ray findings, breathing test results, and a smoking history as defined in the study.
- •People with cystic fibrosis (CF) can join if they have a known CFTR gene variant or CF symptoms and clinical features; CF children over 8 can be included.
- •Some research volunteers can join as control groups if they have no pulmonary disease (and, for the diabetes control group, no history of diabetes or coronary artery disease).
🚫 You may not be able to join if…
- •People younger than 18 or older than 90 are not included (with several listed exceptions tied to specific conditions or specific approvals).
- •Anyone who cannot do reliable pulmonary function testing is excluded.
- •For the bronchoscopy part, people may not join if they have contraindications to fiberoptic bronchoscopy (with lavage and/or bronchial brushing) or if their illness is judged too risky for the procedure.
- •For the bronchoscopy part, people with an allergy to topical anesthetic (such as lidocaine), a recent respiratory infection (within the last 4 weeks), or pregnancy/lactation cannot join.
- •For the bronchoscopy part, people under 18 or over 65 cannot join.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 2–90
- ✓Have Heart / cardiovascular disease or COPD (chronic lung disease) or Asthma
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
What you need to know before you apply
What is this study testing?+
This study is designed to evaluate the genetics involved in the development of lung disease by surveying genes involved in the process of breathing and examining the genes in lung cells of patients with lung disease. The study will focus on defining the distribution of abnormal genes responsible for processes directly involved in different diseases affecting the lungs of patients and healthy volunteers.
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT00001532 · Locations: Maryland