Occupational Exposure Clinical Trial
Official title:
Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic
NCT number | NCT06323603 |
Other study ID # | 3-1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 30, 2023 |
Est. completion date | September 2024 |
The biomonitoring study aims to evaluate genotoxic damage and other parameters of exposure in different occupational exposed populations that work directly with different plastics.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | September 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Aged over 18 years. - Healthy subjects defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urine analysis. - Able to participate and willing to give written informed consent and to comply with the study restrictions. - Have been working at the company for the last 48 months Exclusion Criteria: - Workers decline participation - Legal incapacity or inability to understand or comply with the requirements of the study. - Any hierarchical subordination to the PI - Clinically significant findings as determined by medical history taking, physical examination, ECG, and vital signs. - Submitted to X-ray in the three previous months |
Country | Name | City | State |
---|---|---|---|
Finland | Textile industry | Helsinki | |
Spain | Recycling company | Alicante | |
Spain | Textile Industry | Alicante | |
Spain | Control recruitment | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Ricard Marcos | Finnish Institute of Occupational Health |
Finland, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Characterization of macro and nanoplastics | The characterization of macro and nanoplastics will be done by Raman spectrosmicroscopy and FTIR (From exhaled breath condensate, blood and urine) | Up to 1 year | |
Primary | Genotoxic evaluation by the Micronucleus assay | Blood and buccal cells will be collected from donors to check for the presence of genotoxic permanent damage | Up to 1 year | |
Primary | Genotoxic evaluation by the Comet assay | Blood will be analysed to check for the presence of genotoxic primary damage | Up to 1 year | |
Primary | Cytokine release | Plasma will be analysed to check for the presence of cytokines | Up to 1 year | |
Primary | Microbiota analysis from feces by MinIOn | Feces will be analysed to check for variations in microbiota in the exposed and control groups | up to 1 year | |
Secondary | Analyses of surrogate biomarkers | Different metabolites will be analysed in the urine of participants, as an indirect measure to detect plastic exposure (p.eg. ftalates).
The selection of the metabolite will depend of other analyses done on the project. |
Up to 1 year |
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