Investigation of MP Pollution in the Human Respiratory System and Its Relationship to Lung Cancer
December 3, 2025 updated by: H. Lee Moffitt Cancer Center and Research Institute
Investigation of Microplastic Pollution in the Human Respiratory System and Its Relationship to Lung Cancer
This project will study and characterize Microplastic (MP) burden in the lungs of patients undergoing Bronchoalveolar Levage (BAL) in thoracic clinics at Moffitt.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
119
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- Moffitt Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Any Moffitt patient undergoing bronchoscopy/bronchoalveolar lavage (BAL) either English or Spanish speaking.
Description
Inclusion Criteria:
- English or Spanish-speaking patients scheduled for bronchoscopy/bronchoalveolar lavage (BAL) in thoracic clinics at Moffitt.
Exclusion Criteria:
- Patients with a known prior history of lung cancer or that have undergone a Bronchoalveolar Lavage (BAL) procedure at any time in the past in the involved lung targeted for BAL.
- Patients that have had any prior lung or thoracic or surgeries or procedures (examples: removal of lung or portions of the involved lung (lobectomy, pneumonectomy, wedge resection/segmentectomy).
- Patients with specimens that are considered to be non-adequate as true Bronchoalveolar Lavage Fluid (BALF) (i.e., absence of alveolar macrophages) after pathologist's evaluation will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Lung Neoplasm
Lung Cancer cases will be comprised of patients that are confirmed to have lung cancer based on bronchoscopy/ Bronchoalveolar Lavage (BAL) and other clinical testing.
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Bronchoalveolar Lavage (BAL) is a standard diagnostic tool for the evaluation of lower respiratory tract pathology including respiratory infections and unexplained radiographic pulmonary lesions including lung neoplasia.
It is a minimally invasive procedure that involves introduction of the bronchoscope, installation of sterile normal saline into a subsegment of the lung, and suction and collection of the recovered saline for diagnostic evaluation.
|
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Lung Neoplasm Excluded
Lung Cancer excluded cases will be comprised of the remaining patients in whom lung cancer is excluded as a diagnosis based on bronchoscopy/ Bronchoalveolar Lavage (BAL) and other clinical testing.
|
Bronchoalveolar Lavage (BAL) is a standard diagnostic tool for the evaluation of lower respiratory tract pathology including respiratory infections and unexplained radiographic pulmonary lesions including lung neoplasia.
It is a minimally invasive procedure that involves introduction of the bronchoscope, installation of sterile normal saline into a subsegment of the lung, and suction and collection of the recovered saline for diagnostic evaluation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Characterization of Microplastic (MP) Burden in the Lungs
Time Frame: Up to 24 Months
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Microplastic (MP) Burden in the Lungs will be determined by the results of the Bronchoscopy/Bronchoalveolar Lavage (BAL). MPs isolated from Bronchoalveolar Fluid (BALF) will be characterized using Raman spectroscopy (RS). RS is a vibrational spectroscopy technique based on the inelastic scattering of light that provides information on the molecular vibrations of a system in the form of a vibrational spectrum. The Raman spectrum is akin to a fingerprint of chemical structure allowing identification of the components present in the sample. For each sample, data will be generated on the presence or absence of MPs, total number of MPs, and polymer subtype distribution of MPs identified in the samples. |
Up to 24 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Concentration of Microplastics (MPs) in Lung Cancer Patients
Time Frame: Up to 24 Months
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Concentration of Microplastics (MPs) will be determined by the number of MPs identified in 10-mLs of Bronchoalveolar Fluid (BALF).
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Up to 24 Months
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Concentration of Microplastics (MPs) in Non-Lung Cancer Patients
Time Frame: Up to 24 Months
|
Concentration of Microplastics (MPs) will be determined by the number of MPs identified in 10-mLs of Bronchoalveolar Fluid (BALF).
|
Up to 24 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kathleen M Egan, ScD, Moffitt Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2024
Primary Completion (Estimated)
September 18, 2026
Study Completion (Estimated)
September 18, 2026
Study Registration Dates
First Submitted
July 26, 2024
First Submitted That Met QC Criteria
July 26, 2024
First Posted (Actual)
July 31, 2024
Study Record Updates
Last Update Posted (Estimated)
December 4, 2025
Last Update Submitted That Met QC Criteria
December 3, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-22605
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.