- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06603675
Microplastics in the Human Respiratory System
Detection and Analysis of Microplastic Subtypes in the Human Respiratory System.
Study Overview
Status
Conditions
Detailed Description
Environmental pollution from plastics has become one of the key global challenges, with microplastics-tiny particles resulting from plastic degradation-being increasingly detected in water, soil, and the atmosphere. Microplastics can enter the human body through ingestion or inhalation. According to studies (Prata et al., 2020), there is a risk of microplastics being present in the human respiratory system, raising public health concerns. Although research on microplastics in human lungs is still in its infancy, some preliminary studies suggest a potential link between their presence and decreased respiratory function or lung diseases (Chen et al., 2022). Hypothetically, microplastics could cause inflammatory reactions, disrupt metabolism, and contribute to lung cancer development. Additionally, it is speculated that inhaled microplastics could settle in lung tissue and spread to other organs through lymphatic and blood vessels, but this hypothesis remains unproven.
Given the limited data and the rising prevalence of respiratory disorders, this study aims to quantify and characterize microplastics present in the lung parenchyma and lymph nodes of patients with lung cancer and other respiratory diseases, such as emphysema or interstitial lung diseases. The study also seeks to clarify the role of microplastics in the development of these conditions. In future stages, the research will focus on uncovering the mechanisms through which microplastics affect lung tissues.
The study model involves analyzing lung tissue and lymph node samples from patients undergoing surgeries for lung cancer, emphysema, and interstitial lung diseases. Microplastic particles will be detected using infrared microspectroscopy (μFTIR). Lung parenchyma, lymph nodes, and blood samples will be collected with patient consent during surgery, and tissues will be stored at -80°C for further analysis.
Following established protocols (Jenner et al., 2022), microplastics will be identified using Fourier Transform Infrared (FTIR) spectroscopy. In addition to microplastic analysis, data on patients' medical history, occupational exposure, respiratory function, smoking habits, and COVID-19 history will be collected alongside surgical and histopathological findings.
The study anticipates detecting microplastics in the respiratory tract and identifying their types. It is possible that this research will establish a correlation between the presence of microplastics and the severity of lung diseases, potentially identifying a new risk factor for respiratory illnesses. Future research will delve deeper into the mechanisms through which microplastics may cause harmful health effects.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Piotr Gabryel, MD, PhD
- Phone Number: +48603444042
- Email: piotrgabryel@gmail.com
Study Contact Backup
- Name: Dominika Zielińska, MD
- Phone Number: +48509091690
- Email: piotrgabryel@gmail.com
Study Locations
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Wielkopolska
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Poznań, Wielkopolska, Poland, 60-569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
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Contact:
- Piotr Gabryel, MD, PhD
- Phone Number: +48 603-444-042
- Email: piotrgabryel@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients undergoing surgery for lung cancer, emphysema, interstitial lung diseases, or other respiratory conditions,
- patients undergoing lung transplantation (lungs removed from transplant recipients),
- age 18 years or older,
- ability to provide informed consent.
Exclusion Criteria:
- patients with a history of recent or ongoing chemotherapy, immunotherapy, or radiation therapy,
- inability or unwillingness to provide informed consent,
- previous lung surgeries,
- insufficient tissue or blood samples available for analysis due to technical or procedural reasons.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of lung microplastics.
Time Frame: Time of surgery (Single time point; microplastic measurement is performed on a lung sample taken during surgery).
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Number of microplastics particles detected per sample of lung tissue or regional lymph nodes obtained from patients during surgery.
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Time of surgery (Single time point; microplastic measurement is performed on a lung sample taken during surgery).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Types of lung microplastics.
Time Frame: Time of surgery (Single time point; microplastic measurement is performed on a lung sample taken during surgery).
|
Types of microplastics particles detected per sample of lung tissue or regional lymph nodes obtained from patients during surgery.
|
Time of surgery (Single time point; microplastic measurement is performed on a lung sample taken during surgery).
|
Collaborators and Investigators
Investigators
- Study Chair: Cezary Piwkowski, MD, Prof., Poznan University of Medical Sciences
Publications and helpful links
General Publications
- Jenner LC, Rotchell JM, Bennett RT, Cowen M, Tentzeris V, Sadofsky LR. Detection of microplastics in human lung tissue using muFTIR spectroscopy. Sci Total Environ. 2022 Jul 20;831:154907. doi: 10.1016/j.scitotenv.2022.154907. Epub 2022 Mar 29.
- Zhao J, Zhang H, Shi L, Jia Y, Sheng H. Detection and quantification of microplastics in various types of human tumor tissues. Ecotoxicol Environ Saf. 2024 Sep 15;283:116818. doi: 10.1016/j.ecoenv.2024.116818. Epub 2024 Jul 30.
- Field DT, Green JL, Bennett R, Jenner LC, Sadofsky LR, Chapman E, Loubani M, Rotchell JM. Microplastics in the surgical environment. Environ Int. 2022 Dec;170:107630. doi: 10.1016/j.envint.2022.107630. Epub 2022 Nov 13.
- Danopoulos E, Jenner LC, Twiddy M, Rotchell JM. Microplastic Contamination of Seafood Intended for Human Consumption: A Systematic Review and Meta-Analysis. Environ Health Perspect. 2020 Dec;128(12):126002. doi: 10.1289/EHP7171. Epub 2020 Dec 23.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MicroLung24
- 2023/07/X/NZ7/00906 (Other Grant/Funding Number: Narodowe Centrum Nauki)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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