Lung CancerNCT06530615
Investigation of MP Pollution in the Human Respiratory System and Its Relationship to Lung Cancer
An observational study of Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This project will study and characterize Microplastic (MP) burden in the lungs of patients undergoing Bronchoalveolar Levage (BAL) in thoracic clinics at Moffitt. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Bronchoalveolar Lavage (BAL) during Bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 18 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any Moffitt patient undergoing bronchoscopy/bronchoalveolar lavage (BAL) either English or Spanish speaking.
Who may be able to join
- English or Spanish-speaking patients scheduled for bronchoscopy/bronchoalveolar lavage (BAL) in thoracic clinics at Moffitt.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lung Cancer
- Being tested
- Bronchoalveolar Lavage (BAL) during Bronchoscopy
- Keywords
- Microplastic Pollution, Human Respiratory System
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoalveolar Lavage (BAL) during BronchoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Bronchoalveolar Lavage (BAL) during Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 Months
Secondary outcomes (2)
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).
Measured: 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).
Measured: Up to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start5 Feb 2024
- Primary completion18 Sep 2026 (estimated)
- Study completion18 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen M Egan, ScD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530615
- Sponsor's protocol ID
- MCC-22605
- Status last verified
- Dec 2025
- First submitted
- 26 Jul 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Microplastic Pollution in the Human Respiratory System and Its Relationship to Lung Cancer
- ClinicalTrials.gov ID
- NCT06530615
- Acronym / sponsor ID
- MCC-22605
- Conditions
- Lung Cancer
- Keywords
- Microplastic Pollution, Human Respiratory System
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 119 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 18 Sep 2026 (estimated)
- Study completion
- 18 Sep 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will study and characterize Microplastic (MP) burden in the lungs of patients undergoing Bronchoalveolar Levage (BAL) in thoracic clinics at Moffitt.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Neoplasm | – | Procedure: Bronchoalveolar Lavage (BAL) during BronchoscopyLung Cancer cases will be comprised of patients that are confirmed to have lung cancer based on bronchoscopy/ Bronchoalveolar Lavage (BAL) and other clinical testing. |
| Lung Neoplasm Excluded | – | Procedure: Bronchoalveolar Lavage (BAL) during BronchoscopyLung 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any Moffitt patient undergoing bronchoscopy/bronchoalveolar lavage (BAL) either English or Spanish speaking.
Key inclusion criteria (1 listed)
- English or Spanish-speaking patients scheduled for bronchoscopy/bronchoalveolar lavage (BAL) in thoracic clinics at Moffitt.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoalveolar Lavage (BAL) during BronchoscopyBronchoalveolar 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. | Procedure or surgery | Lung Neoplasm, Lung Neoplasm Excluded |
Primary outcome
Characterization of Microplastic (MP) Burden in the Lungs
Time frame: Up to 24 Months
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.
2 secondary outcomes
Concentration of Microplastics (MPs) in Lung Cancer Patients
Time frame: Up to 24 Months
Concentration of Microplastics (MPs) in Non-Lung Cancer Patients
Time frame: Up to 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M Egan, ScD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of Microplastic (MP) Burden in the Lungs (time frame: Up to 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.