- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00740337
Factors That Affect the Development of COPD Symptoms
Specialized Center of Clinically Oriented Research: Alveolar and Airway Mechanisms of COPD. Airway Determinants: Innate Immune Signaling (Project 4)
Přehled studie
Postavení
Detailní popis
COPD is a chronic lung disease in which the lungs' airways and balloon-like air sacs, called alveoli, are damaged, lose their shape, and become floppy. As a result, they cannot fully inflate to allow the maximum amount of air through. COPD is usually the result of many years of cigarette smoking. Breathing in other kinds of lung irritants, such as pollution, dust, or chemicals, over a long period of time may also cause or contribute to COPD. Some people with COPD have an excess of mucus in their lungs, possibly caused by an overactive immune response, which can lead to coughing and shortness of breath. Although cigarette smoking seems to make this symptom worse, researchers are not sure why it occurs in some people and not others. This study will examine and compare blood and lung tissue samples from smokers and nonsmokers with and without COPD to determine what physiological differences, environmental factors, genes, and biomarkers contribute to the development of and symptoms associated with COPD.
Before their scheduled lung resection surgery, participants in this study will attend one study visit. It will last approximately 1 to 2 hours and will consist of answering questions about medical history, filling out health questionnaires, and providing a blood sample. After the surgery, study researchers will take the lung tissue that was removed and examine it in a laboratory. Participants will be contacted by study staff if, when examining the lung tissue, researchers discover that a participant has a medical disorder that current treatment can stop or improve. Also, participants will be contacted at the end of the study to answer brief questions about their health.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Missouri
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Saint Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Ability to read and write in English
- Able to participate in the informed consent process
- Planned lung resection at BJH
- Acceptable pulmonary function tests done at BJH within 1 month of enrollment
- Acceptable chest CT scan done at BJH within 3 years of enrollment
Exclusion Criteria:
- Pregnant
- Prisoner
- Vulnerable populations
- Clinically significant lung disease other than COPD and the indication for resection (e.g., cystic fibrosis, bronchiectasis, obliterative bronchiolitis, airway lesion)
- Coexisting active chronic inflammatory or collagen vascular disease, immune deficiency of any kind, or previous organ transplant
- Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated)
- Systemic chemotherapy within past 1 month (30 days)
- Hematologic malignancy or thoracic radiation within past year
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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COPD
Participants in this group will be people who have COPD and plan to undergo lung resection surgery at Barnes-Jewish Hospital (BJH).
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Control
Participants in this group will be people who do not have COPD and plan to undergo lung resection surgery at BJH.
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Michael J. Holtzman, MD, Pulmonary and Critical Care, Washington University School of Medicine
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 582
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