NCT06603675

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Sep 2024Jul 2026

First Submitted

Initial submission to the registry

September 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

September 30, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

September 17, 2024

Last Update Submit

October 1, 2024

Conditions

Keywords

microplasticslungrespiratory systemlung cancertransplantation

Outcome Measures

Primary Outcomes (1)

  • Number of lung microplastics.

    Number 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).

Secondary Outcomes (1)

  • Types of lung microplastics.

    Time of surgery (Single time point; microplastic measurement is performed on a lung sample taken during surgery).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Poznan, Wielkopolska, 60-569, Poland

Location

Related Publications (4)

  • 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.

    PMID: 39083862BACKGROUND
  • 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.

    PMID: 36403328BACKGROUND
  • 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.

    PMID: 33355482BACKGROUND
  • 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.

    PMID: 35364151BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Lung parenchyma, lymph nodes, and blood samples will be collected from patients undergoing surgery for lung diseases.

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Cezary Piwkowski, MD, Prof.

    Poznan University of Medical Sciences

    STUDY CHAIR

Central Study Contacts

Piotr Gabryel, MD, PhD

CONTACT

Dominika Zielińska, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 19, 2024

Study Start

September 30, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Only IPD used in the results publication will be shared

Time Frame
Beginning 2 months and ending 5 years after the publication of results.
Access Criteria
A proposal that describes planned analyses mjust be submitted to central contact person.

Locations