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

NCT06530615 | Active Not Recruiting

• 1 other identifier: MCC-22605
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

This project will study and characterize Microplastic (MP) burden in the lungs of patients undergoing Bronchoalveolar Levage (BAL) in thoracic clinics at Moffitt.

Conditions

Lung Cancer

Keywords

Microplastic Pollution; Human Respiratory System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Concentration of Microplastics (MPs) in Lung Cancer Patients

  Up to 24 Months

• Concentration of Microplastics (MPs) in Non-Lung Cancer Patients

  Up to 24 Months

Study Arms (2)

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

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

Interventions

Bronchoalveolar Lavage (BAL) during Bronchoscopy PROCEDURE

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; Lung Neoplasm Excluded

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any Moffitt patient undergoing bronchoscopy/bronchoalveolar lavage (BAL) either English or Spanish speaking.

You may qualify if:

• English or Spanish-speaking patients scheduled for bronchoscopy/bronchoalveolar lavage (BAL) in thoracic clinics at Moffitt.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials Website

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• Kathleen M Egan, ScD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: February 5, 2024
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): September 18, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)