Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077909
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2004-02-12
Brief Title:
Study of Lung Proteins in Patients With Pneumonia
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Biomarkers and Protein Mass Expression Profiles in Bronchoalveolar Lavage From Patients With Lung Infiltrates
Status:
RECRUITING
Status Verified Date:
2024-06-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 patients 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salt water is then injected through the bronchoscope into the air passage acting as a rinse A sample of fluid is then withdrawn for microscopic examination Researchers in the current study will use some of the fluid obtained from the lavage to examine for protein content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
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 patients 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
Detailed Description:
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 proteinpeptide 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 eg 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 1000 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 proteinpeptide 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 eg 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 1000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-CC-0119 | None | None | None |