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Biomarkers and Protein Mass Expression Profiles in Bronchoalveolar Lavage From Patients With Lung Infiltrates

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Infections+2

+ Lung Diseases

+ Pneumonia

From 3 to 99 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2004
See protocol details

Summary

Principal SponsorNational Institutes of Health Clinical Center (CC)
Study ContactGloria Y Pastor, R.N.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 20, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleBiomarkers and Protein Mass Expression Profiles in Bronchoalveolar Lavage From Patients With Lung Infiltrates
NCT00077909
Principal SponsorNational Institutes of Health Clinical Center (CC)
Study ContactGloria Y Pastor, R.N.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

750 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsLung DiseasesPneumoniaRespiratory Tract DiseasesRespiratory Tract Infections

Criteria

2 inclusion criteria required to participate
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.

A parent/guardian may provide consent for a child age 17 or under and a Legally Authorized Representative (LAR) may provide consent for adults unable to consent.

1 exclusion criteria prevent from participating
Patients undergoing bronchoscopy but not wanting to participate with either the chart review or the proteomic analysis of BAL fluid supernatant will be excluded.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
Recruiting
One Study Center