Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-31 @ 6:40 AM
Study NCT ID:
NCT06323603
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood, exhaled breath condensate, exfoliated buccal cells, urine and feces'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2024-03-14', 'studyFirstSubmitQcDate': '2024-03-14', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of macro and nanoplastics', 'timeFrame': 'Up to 1 year', 'description': 'The characterization of macro and nanoplastics will be done by Raman spectrosmicroscopy and FTIR (From exhaled breath condensate, blood and urine)'}, {'measure': 'Genotoxic evaluation by the Micronucleus assay', 'timeFrame': 'Up to 1 year', 'description': 'Blood and buccal cells will be collected from donors to check for the presence of genotoxic permanent damage'}, {'measure': 'Genotoxic evaluation by the Comet assay', 'timeFrame': 'Up to 1 year', 'description': 'Blood will be analysed to check for the presence of genotoxic primary damage'}, {'measure': 'Cytokine release', 'timeFrame': 'Up to 1 year', 'description': 'Plasma will be analysed to check for the presence of cytokines'}, {'measure': 'Microbiota analysis from feces by MinIOn', 'timeFrame': 'up to 1 year', 'description': 'Feces will be analysed to check for variations in microbiota in the exposed and control groups'}], 'secondaryOutcomes': [{'measure': 'Analyses of surrogate biomarkers', 'timeFrame': 'Up to 1 year', 'description': 'Different metabolites will be analysed in the urine of participants, as an indirect measure to detect plastic exposure (p.eg. ftalates).\n\nThe selection of the metabolite will depend of other analyses done on the project.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Biomonitoring', 'Genotoxic damage', 'Micro and nanoplastic'], 'conditions': ['Occupational Exposure', 'Genotoxicity', 'Damage Dna']}, 'descriptionModule': {'briefSummary': 'The biomonitoring study aims to evaluate genotoxic damage and other parameters of exposure in different occupational exposed populations that work directly with different plastics.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nDifferent 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.\n\nAt 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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged over 18 years.\n* 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.\n* Able to participate and willing to give written informed consent and to comply with the study restrictions.\n* Have been working at the company for the last 48 months\n\nExclusion Criteria:\n\n* Workers decline participation\n* Legal incapacity or inability to understand or comply with the requirements of the study.\n* Any hierarchical subordination to the PI\n* Clinically significant findings as determined by medical history taking, physical examination, ECG, and vital signs.\n* Submitted to X-ray in the three previous months'}, 'identificationModule': {'nctId': 'NCT06323603', 'briefTitle': 'Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Autonoma de Barcelona'}, 'officialTitle': 'Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic', 'orgStudyIdInfo': {'id': '3-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1. Textile industry workers', 'description': 'Workers from the textile industry, that manufactures non-wovens fibers', 'interventionNames': ['Other: Micro and nanoplastic']}, {'label': '2. Plastic Recycling Workers', 'description': 'Workers involved in recycling and waste management of plastic', 'interventionNames': ['Other: Micro and nanoplastic']}, {'label': '3. Controls', 'description': 'Control group that will match the characteristics of grup 1 and 2'}], 'interventions': [{'name': 'Micro and nanoplastic', 'type': 'OTHER', 'description': 'Biological samples will be obtained to evaluate the different biomarkers selected', 'armGroupLabels': ['1. Textile industry workers', '2. Plastic Recycling Workers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'status': 'COMPLETED', 'country': 'Finland', 'facility': 'Textile industry', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Alicante', 'status': 'COMPLETED', 'country': 'Spain', 'facility': 'Recycling company', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Alicante', 'status': 'COMPLETED', 'country': 'Spain', 'facility': 'Textile Industry', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Susana Pastor', 'role': 'CONTACT'}], 'facility': 'Control recruitment', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Alba Hernández, Professor', 'role': 'CONTACT', 'email': 'alba.hernandez@uab.cat', 'phone': '+34 93 581 4702'}], 'overallOfficials': [{'name': 'Julia Catalan, Researcher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FIOH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ricard Marcos', 'class': 'OTHER'}, 'collaborators': [{'name': 'Finnish Institute of Occupational Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ricard Marcos', 'investigatorAffiliation': 'Universitat Autonoma de Barcelona'}}}}