Occupational ExposureNCT06323603
Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic
An observational study of Occupational Exposure and Genotoxicity, run by Ricard Marcos at 4 sites in 2 countries.
Trial summary
The biomonitoring study aims to evaluate genotoxic damage and other parameters of exposure in different occupational exposed populations that work directly with different plastics. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Occupational Exposure, Genotoxicity, Damage Dna
- What is being tested?
- Micro and nanoplastic
- How many people
- 45 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 30 Jun 2023to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study aims to determine whether workers occupationally exposed to different plastics show increased genomic damage, changes in cytokine expression and/ or microbiota. Moreover, the levels of macro/microplastics in different body fluids will be characterized. Different European populations dedicated to the recycling of plastics and the production of non-woven textiles will be used, as well as a control group that will match according to the characteristics of the populations. At least 50 workers from each of the participating industries will be used to demonstrate a higher exposure MNPLs level and, therefore, an increased health risk.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Spain3 sites, 1 recruiting
- Completed
Recycling company
Alicante
- Completed
Textile Industry
Alicante
- Recruiting
Control recruitment
Barcelona
Susana Pastor
About this study
The biomonitoring study aims to evaluate genotoxic damage and other parameters of exposure in different occupational exposed populations that work directly with different plastics.
Read the detailed description
The exponential increase in the production and use of plastic goods translates into a parallel increase of environmental plastic waste that is continuously degraded into micro and nanoplastics (MNPLs). Information on their effects on human health is still preliminary, especially regarding human biomonitoring studies, thus more information is required for risk assessment evaluation.
This observational study aims to evaluate the exposure to MNPLs in human populations occupationally exposed to different types of plastics (fibers and plastic waste). The study will evaluate the effect of exposure to MNPLs (genotoxic and microbiota effects) in different body samples (blood, exfoliated buccal cells, urine,and feces) and also will use those samples to evaluate the presence of MNPLs.
- Conditions
- Occupational Exposure, Genotoxicity, Damage Dna
- Being tested
- Micro and nanoplastic
- Keywords
- Biomonitoring, Genotoxic damage, Micro and nanoplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro and nanoplasticOther
Biological samples will be obtained to evaluate the different biomarkers selected
| Study group | Role | What they receive |
|---|---|---|
| 1. Textile industry workers | Workers from the textile industry, that manufactures non-wovens fibers Receives: Other: Micro and nanoplastic | |
| 2. Plastic Recycling Workers | Workers involved in recycling and waste management of plastic Receives: Other: Micro and nanoplastic | |
| 3. Controls | Control group that will match the characteristics of grup 1 and 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 1 year
Genotoxic evaluation by the Micronucleus assay
Blood and buccal cells will be collected from donors to check for the presence of genotoxic permanent damage
Measured: Up to 1 year
Genotoxic evaluation by the Comet assay
Blood will be analysed to check for the presence of genotoxic primary damage
Measured: Up to 1 year
Cytokine release
Plasma will be analysed to check for the presence of cytokines
Measured: Up to 1 year
Microbiota analysis from feces by MinIOn
Feces will be analysed to check for variations in microbiota in the exposed and control groups
Measured: up to 1 year
Secondary outcomes (1)
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start30 Jun 2023
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational ExposureStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ricard Marcos
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Institute of Occupational Health
- Responsible party
- Sponsor-investigator, Ricard Marcos, Universitat Autonoma de Barcelona
- Investigators
- Julia Catalan, Researcher, Principal investigator, FIOH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323603
- Sponsor's protocol ID
- 3-1
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic
- ClinicalTrials.gov ID
- NCT06323603
- Acronym / sponsor ID
- 3-1
- Conditions
- Occupational Exposure, Genotoxicity, Damage Dna
- Keywords
- Biomonitoring, Genotoxic damage, Micro and nanoplastic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ricard MarcosUniversity, hospital or other
- Collaborators
- Finnish Institute of Occupational Health
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 21 Mar 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.
The biomonitoring study aims to evaluate genotoxic damage and other parameters of exposure in different occupational exposed populations that work directly with different plastics.
Detailed description
The exponential increase in the production and use of plastic goods translates into a parallel increase of environmental plastic waste that is continuously degraded into micro and nanoplastics (MNPLs). Information on their effects on human health is still preliminary, especially regarding human biomonitoring studies, thus more information is required for risk assessment evaluation.
This observational study aims to evaluate the exposure to MNPLs in human populations occupationally exposed to different types of plastics (fibers and plastic waste). The study will evaluate the effect of exposure to MNPLs (genotoxic and microbiota effects) in different body samples (blood, exfoliated buccal cells, urine,and feces) and also will use those samples to evaluate the presence of MNPLs.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Textile industry workers | – | Other: Micro and nanoplasticWorkers from the textile industry, that manufactures non-wovens fibers |
| 2. Plastic Recycling Workers | – | Other: Micro and nanoplasticWorkers involved in recycling and waste management of plastic |
| 3. Controls | – | –Control group that will match the characteristics of grup 1 and 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study aims to determine whether workers occupationally exposed to different plastics show increased genomic damage, changes in cytokine expression and/ or microbiota. Moreover, the levels of macro/microplastics in different body fluids will be characterized. Different European populations dedicated to the recycling of plastics and the production of non-woven textiles will be used, as well as a control group that will match according to the characteristics of the populations. At least 50 workers from each of the participating industries will be used to demonstrate a higher exposure MNPLs level and, therefore, an increased health risk.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Micro and nanoplasticBiological samples will be obtained to evaluate the different biomarkers selected | Other | 1. Textile industry workers, 2. Plastic Recycling Workers |
Primary outcome
Characterization of macro and nanoplastics
Time frame: Up to 1 year
The characterization of macro and nanoplastics will be done by Raman spectrosmicroscopy and FTIR (From exhaled breath condensate, blood and urine)
Genotoxic evaluation by the Micronucleus assay
Time frame: Up to 1 year
Blood and buccal cells will be collected from donors to check for the presence of genotoxic permanent damage
Genotoxic evaluation by the Comet assay
Time frame: Up to 1 year
Blood will be analysed to check for the presence of genotoxic primary damage
Cytokine release
Time frame: Up to 1 year
Plasma will be analysed to check for the presence of cytokines
Microbiota analysis from feces by MinIOn
Time frame: up to 1 year
Feces will be analysed to check for variations in microbiota in the exposed and control groups
1 secondary outcome
Analyses of surrogate biomarkers
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
Related trials for Occupational Exposure
RecruitingObservational study
Admission and Management of Occupational or Other Exposures to Biodefense/Bioterrorism Agents or to Epidemic/Emerging Infectious Diseases
Occupational Accidents, Incubation Period, Infectious Disese
Recruiting
Effect of a Dietary Supplement Versus Placebo on Serum PFAS Levels in Male Firefighters
Environmental Exposure, PFAS Exposure
Recruiting
Consecutive Occupational Heat Exposure With and Without Overnight Cooling
Body Temperature Changes, Heat Stress
Enrolling by invitation
Personalizing Veterans' Lung Cancer Screening and Diagnosis
Lung Cancer Screening, Military Service-related Environmental and Occupational Exposures
Not yet recruiting
Progressive Heat Exposure and Physiological Strain
Body Temperature Changes, Heat Stress
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.
Julia Catalan, Researcher principal investigator
FIOH
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Exposure and Genotoxicity, run by Ricard Marcos at 4 sites in 2 countries.
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 5 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alba Hernández, Professor (+34 93 581 4702, alba.hernandez@uab.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of macro and nanoplastics (time frame: Up to 1 year). The study lists 5 primary outcomes in all. 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 25 Mar 2024.