Investigation of MP Pollution in the Human Respiratory System and Its Relationship to Lung Cancer

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: Lung Cancer
• Intervention / Treatment: Procedure: Bronchoalveolar Lavage (BAL) during Bronchoscopy

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Bronchoalveolar Lavage (BAL) during Bronchoscopy; 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.
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.	Procedure: Bronchoalveolar Lavage (BAL) during Bronchoscopy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of Microplastic (MP) Burden in the Lungs	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
Concentration of Microplastics (MPs) in Lung Cancer Patients	Concentration of Microplastics (MPs) will be determined by the number of MPs identified in 10-mLs of Bronchoalveolar Fluid (BALF).	Up to 24 Months
Concentration of Microplastics (MPs) in Non-Lung Cancer Patients	Concentration of Microplastics (MPs) will be determined by the number of MPs identified in 10-mLs of Bronchoalveolar Fluid (BALF).	Up to 24 Months

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Kathleen M Egan, ScD, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials Website

Study record dates

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

• Keywords: Microplastic Pollution; Human Respiratory System
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Investigative Techniques; Therapeutic Irrigation; Bronchoalveolar Lavage
• 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