Study of Lung Proteins in Patients With Pneumonia
| Status: | Recruiting |
|---|---|
| Conditions: | Pneumonia, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 3 - 99 |
| Updated: | 3/10/2019 |
| Start Date: | February 20, 2004 |
| Contact: | Debra Reda, R.N. |
| Email: | dreda@nih.gov |
| Phone: | (301) 496-9320 |
Biomarkers and Protein Mass Expression Profiles in Bronchoalveolar Lavage From Patients With Lung Infiltrates
This study will examine the different types of proteins present in the lungs of patients with
pneumonia to explore the causes of different types of the disease. Pneumonia is a condition
that causes lung inflammation AND is often caused by an infection. It is usually diagnosed by
lung x-rays and listening to the chest with a stethoscope. This method can diagnose
pneumonia, but it does not provide information on the cause of the inflammation - information
that might be helpful in guiding treatment. This study will measure proteins in the lungs of
patients to see if certain proteins are associated with specific forms of pneumonia, and can
thus serve as biomarkers for disease.
Patients undergoing diagnostic bronchoscopy at the NIH Clinical Center may participate in
this study. Patients will undergo bronchoscopy and bronchoalveolar lavage as scheduled for
their medical care. For this procedure, the patient's mouth and throat are numbed with
lidocaine; a sedative may be given for comfort. A thin flexible tube called a bronchoscope is
advanced through the nose or mouth into the lung airways to examine the airways carefully.
Saline (salt water) is then injected through the bronchoscope into the air passage, acting as
a rinse. A sample of fluid is then withdrawn for microscopic examination. Researchers in the
current study will use some of the fluid obtained from the lavage to examine for protein
content.
In addition to the bronchoscopy and bronchoalveolar lavage, participants will have about 2
tablespoons of blood drawn to compare blood test results with the results of the lung
washings. Patients' medical records will be reviewed to obtain information on past medical
history, current medical treatment, vital signs, and results of x-ray tests.
pneumonia to explore the causes of different types of the disease. Pneumonia is a condition
that causes lung inflammation AND is often caused by an infection. It is usually diagnosed by
lung x-rays and listening to the chest with a stethoscope. This method can diagnose
pneumonia, but it does not provide information on the cause of the inflammation - information
that might be helpful in guiding treatment. This study will measure proteins in the lungs of
patients to see if certain proteins are associated with specific forms of pneumonia, and can
thus serve as biomarkers for disease.
Patients undergoing diagnostic bronchoscopy at the NIH Clinical Center may participate in
this study. Patients will undergo bronchoscopy and bronchoalveolar lavage as scheduled for
their medical care. For this procedure, the patient's mouth and throat are numbed with
lidocaine; a sedative may be given for comfort. A thin flexible tube called a bronchoscope is
advanced through the nose or mouth into the lung airways to examine the airways carefully.
Saline (salt water) is then injected through the bronchoscope into the air passage, acting as
a rinse. A sample of fluid is then withdrawn for microscopic examination. Researchers in the
current study will use some of the fluid obtained from the lavage to examine for protein
content.
In addition to the bronchoscopy and bronchoalveolar lavage, participants will have about 2
tablespoons of blood drawn to compare blood test results with the results of the lung
washings. Patients' medical records will be reviewed to obtain information on past medical
history, current medical treatment, vital signs, and results of x-ray tests.
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.
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.
- INCLUSION CRITERIA:
All eligible patients undergoing diagnostic bronchoscopy who provide consent for proteomic
analysis of BAL fluid supernatant and chart review of patient characteristics will be
included in this study.
EXCLUSION CRITERIA:
Patients undergoing bronchoscopy but not wanting to participate with either the chart
review or the proteomic analysis of BAL fluid supernatant will be excluded.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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