Biomarkers and Protein Mass Expression Profiles in Bronchoalveolar Lavage From Patients With Lung Infiltrates
Collecte de données
Données recueillies à un instant précis - TransversaleInfections+2
+ Maladies pulmonaires
+ Pneumonie
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 20 février 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVE: The objective of this study is to analyze bronchoalveolar lavage (BAL) fluid from patients with lung infiltrates in order to discover new biomarkers and protein/peptide expression patterns that are associated with specific types of pulmonary diseases and infections. Bronchoalveolar lavage (BAL) is a standard method to obtain lower airway samples to evaluate pulmonary infiltrates in order to diagnose infection, malignancy or non-infectious inflammation. After collecting the BAL (during a clinically indicated brochoscopy), samples are routinely sent to the clinical microbiology laboratory for stains, cultures and molecular analysis. We have recently developed a rapid, culture-independent method to identify unique peptide markers in BAL that identify specific bacterial species. We are expanding the scope of 04-CC-0119 that was based originally on collection of BAL supernatant only, to now collect, analyze and store whole (unprocessed) BAL. The availabilty of new methods of analyzing BAL will broaden the scope of the study to analyze BAL proteins, lung cells, and microbial pathogens. This will allow improved characterization of the host response to lung inflammation and infection and help to assess the feasibility of using the culture-independent approach on clinical BAL samples to identify specific pathogens. POPULATION: The study population will include all patients undergoing bronchoscopy for clinical indications at the Clinical Center who provide informed consent for chart review blood draw (optional), and analysis of BAL, as described in this protocol. We plan to acquire BAL samples that reflect a spectrum of community-acquired and opportunistic pathogens associated with pulmonary disease. In addition analysis of a range of non-infectious pulmonary processes (e.g. acute lung injury, acute respiratory distress syndrome and engraftment syndrome) is important to develop measures of sensitivity and specificity. DESIGN: This is a prospective observational study. OUTCOME: The expected outcome is to: Develop a database of protein mass profiles of BAL fluid linked to specific microbiologic diagnoses. To collect, analyze and store BAL to validate the usefulness of the genoproteomic culture-independent method of microbial identification. To analyze lung cells associated with infectious or inflammatory pulmonary condidtions. Our plan is to acquire 1,000 specimens from the Clinical Center with a range of clinical diagnoses including bacterial, viral, parasitic and fungal infections and sterile inflammation. When a sufficient number of samples in an individual category is collected (approximately 20-30), the samples will be analyzed with current proteomic techniques.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.750 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 3 à 99 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
National Institutes of Health Clinical Center
Bethesda, United StatesOuvrir National Institutes of Health Clinical Center dans Google Maps