MicroplasticsNCT06603675
Microplastics in the Human Respiratory System
An observational study of Microplastics and Lung Cancer (NSCLC), run by Wielkopolskie Centrum Pulmonologii i Torakochirurgii at 1 site in Poland.
Trial summary
Environmental pollution from plastics has become a significant global issue, with microplastics-tiny particles resulting from plastic degradation-being increasingly detected in various environments, including aquatic ecosystems, soil, and air. These particles can enter the human body through ingestion or inhalation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microplastics, Lung Cancer (NSCLC), Lung Transplantation
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 30 Sep 2024to 31 Jul 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: The study group comprises patients from the Department of Thoracic Surgery at Poznan University of Medical Sciences, Wielkopolskie Centrum Pulmonologii i Torakochirurgii. Participants include individuals undergoing surgery for lung cancer, other respiratory diseases such as emphysema and interstitial lung diseases, and lung transplantation (lungs removed from transplant recipients). The group includes individuals with diverse backgrounds, varying occupational exposure histories, smoking status (active and passive), e-cigarette use, and different comorbid conditions.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, Wielkopolska, 60-569
Piotr Gabryel, MD, PhD, +48 603-444-042, piotrgabryel@gmail.com
About this study
Official title: Detection and Analysis of Microplastic Subtypes in the Human Respiratory System.
Environmental pollution from plastics has become a significant global issue, with microplastics-tiny particles resulting from plastic degradation-being increasingly detected in various environments, including aquatic ecosystems, soil, and air. These particles can enter the human body through ingestion or inhalation. Despite growing concerns, little is known about the prevalence and types of microplastics in human lungs. Some studies suggest that microplastics may negatively impact respiratory function and lead to lung diseases. Hypothetically, they could cause inflammation, metabolic disorders, and contribute to lung cancer development. However, research is still in its early stages, and conclusive evidence about the mechanisms linking microplastics to negative health effects is lacking. This study aims to quantify and characterize microplastics in the lung parenchyma and lymph nodes of patients with lung cancer and other respiratory diseases. Tissue samples will be collected during surgeries, and microplastic particles will be detected using FTIR microspectroscopy. The research may contribute to a better understanding of the role of microplastics in the development of respiratory diseases.
Read the 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.
- Conditions
- Microplastics, Lung Cancer (NSCLC), Lung Transplantation
- Keywords
- microplastics, lung, respiratory system, lung cancer, transplantation
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of lung microplastics.
Number of microplastics particles detected per sample of lung tissue or regional lymph nodes obtained from patients during surgery.
Measured: Time of surgery (Single time point; microplastic measurement is performed on a lung sample taken during surgery).
Secondary outcomes (1)
Types of lung microplastics.
Types of microplastics particles detected per sample of lung tissue or regional lymph nodes obtained from patients during surgery.
Measured: Time of surgery (Single time point; microplastic measurement is performed on a lung sample taken during surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2024 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MicroplasticsStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Gabryel, MD, Wielkopolskie Centrum Pulmonologii i Torakochirurgii
- Investigators
- Cezary Piwkowski, MD, Prof., Study chair, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603675
- Sponsor's protocol ID
- MicroLung24
- Other IDs
- 2023/07/X/NZ7/00906
- Status last verified
- Oct 2024
- First submitted
- 17 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication will be shared
Publications
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.
PubMed 39083862Field 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.
PubMed 36403328Danopoulos 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.
PubMed 33355482Jenner 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.
PubMed 35364151
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Analysis of Microplastic Subtypes in the Human Respiratory System.
- ClinicalTrials.gov ID
- NCT06603675
- Acronym / sponsor ID
- MicroLung24
- Conditions
- Microplastics, Lung Cancer (NSCLC), Lung Transplantation
- Keywords
- microplastics, lung, respiratory system, lung cancer, transplantation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wielkopolskie Centrum Pulmonologii i TorakochirurgiiUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 19 Sep 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.
Environmental pollution from plastics has become a significant global issue, with microplastics-tiny particles resulting from plastic degradation-being increasingly detected in various environments, including aquatic ecosystems, soil, and air. These particles can enter the human body through ingestion or inhalation. Despite growing concerns, little is known about the prevalence and types of microplastics in human lungs. Some studies suggest that microplastics may negatively impact respiratory function and lead to lung diseases. Hypothetically, they could cause inflammation, metabolic disorders, and contribute to lung cancer development. However, research is still in its early stages, and conclusive evidence about the mechanisms linking microplastics to negative health effects is lacking. This study aims to quantify and characterize microplastics in the lung parenchyma and lymph nodes of patients with lung cancer and other respiratory diseases. Tissue samples will be collected during surgeries, and microplastic particles will be detected using FTIR microspectroscopy. The research may contribute to a better understanding of the role of microplastics in the development of respiratory diseases.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study group comprises patients from the Department of Thoracic Surgery at Poznan University of Medical Sciences, Wielkopolskie Centrum Pulmonologii i Torakochirurgii. Participants include individuals undergoing surgery for lung cancer, other respiratory diseases such as emphysema and interstitial lung diseases, and lung transplantation (lungs removed from transplant recipients). The group includes individuals with diverse backgrounds, varying occupational exposure histories, smoking status (active and passive), e-cigarette use, and different comorbid conditions.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of lung microplastics.
Time frame: Time of surgery (Single time point; microplastic measurement is performed on a lung sample taken during surgery).
Number of microplastics particles detected per sample of lung tissue or regional lymph nodes obtained from patients during surgery.
1 secondary outcome
Types of lung microplastics.
Time frame: Time of surgery (Single time point; microplastic measurement is performed on a lung sample taken during surgery).
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 3 Oct 2024.
- Background: PubMed 39083862Zhao 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.
- Background: PubMed 36403328Field 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.
- Background: PubMed 33355482Danopoulos 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.
- Background: PubMed 35364151Jenner 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.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication will be shared
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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.
Cezary Piwkowski, MD, Prof. study chair
Poznan University of Medical Sciences
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 Microplastics and Lung Cancer (NSCLC), run by Wielkopolskie Centrum Pulmonologii i Torakochirurgii at 1 site in Poland.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Oct 2024. 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 Poland. 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?
Contact Piotr Gabryel, MD, PhD (+48603444042, piotrgabryel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of lung microplastics. (time frame: Time of surgery (Single time point; microplastic measurement is performed on a lung sample taken during surgery).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06603675, which also lists 4 linked publications.
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 3 Oct 2024.