Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT05256212
Status:
COMPLETED
Last Update Posted:
2024-07-31
First Post:
2022-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Occupational Exposure of Firefighters to Environmental Pollutants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'urine, serum, full blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2022-01-10', 'studyFirstSubmitQcDate': '2022-02-24', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PBDEs levels, measured in serum by GC-MS', 'timeFrame': 'Day 1- day of recruitment', 'description': 'to test for PBDE levels in blood'}, {'measure': 'BTEX levels, measured in urine by LC-MS/MS', 'timeFrame': 'Day 1- day of recruitment', 'description': 'to test for BTEX levels in blood'}, {'measure': 'Heavy metals (Pb, Hg, Cd) levels, measured in urine by ICP-MS', 'timeFrame': 'Day 1- day of recruitment', 'description': 'to test for Heavy metals levels'}], 'secondaryOutcomes': [{'measure': 'Liver enzymes levels (x2 of Upper Limit of Normal), measured in serum', 'timeFrame': 'Day 1- day of recruitment', 'description': 'to test for liver function'}, {'measure': 'renal function (eGFR<60), by creatinine level measured in serum', 'timeFrame': 'Day 1- day of recruitment', 'description': 'to test for renal function'}, {'measure': 'Thyroid function (TSH or FT4 out of lab reference values) measured in serum', 'timeFrame': 'Day 1- day of recruitment', 'description': 'to test for thyroid function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of the current trial is to assess the exposure of firefighters (FF) to environmental pollutants emitted from fires, to explore the association of exposure with their health status and to compare these data with those of non-FF participants', 'detailedDescription': 'Occupational exposure of firefighters to environmental contaminants Background Firefighters (FF) are exposed during their firefighting activities to a vast array of contaminants and toxic gases vapors that are released into the environment as results of combustion. Between those materials, there are heavy metals, brominated flame retardants (Polybrominated diphenyl ethers, PBDEs) and Volatile organic Compounds (VOC) that include between others Benzene, Toluene, Ethylbenzene and Xylene (BTEX).In the last decade a concern for negative health impact for all these contaminants appeared.\n\nThere is a vast use of these materials in the production of cars, furniture, electrical appliances, mattresses, paints, etc. These materials are released into the environment and absorbed by the human body.\n\nThere are some groups with increased exposure to these materials in comparison to the general population, as results of occupational exposure. Some of these groups include FF, workers who recycle electronic equipment and furniture manufacture workers.\n\nPurposes:\n\n1. to measure the levels of PBDEs, heavy metals and BTEX metabolites in the blood and urine of FF who are exposed to fires during their work\n2. to evaluate the association between the levels of these materials and the health status of the participants. This will be done using a health questionnaire and the results of blood tests showing liver, renal and thyroid functions.\n3. to compare their exposure levels and health status with those of general population\n\nThis is a prospective observational trial in a FF group. Exposure data from the activity log for each of the FF will also be collected.\n\nBromide flame retardants PBDEs\n\nThese materials are added during the manufacture process to many products such as: plastic, textile, furnitures, mattresses and electric equipment in order to reduce their flammability.\n\nThere are 5 main groups of flame retardants and more than 75 different kinds. BSEF (2006) reported the highest consumption of decaBDE at 65.7 kt in 2002, The wide manufacture and use of PBDEs increases their release and their accumulation in the environment with time.\n\nAlthough PBDEs increase the safety of products in times of fire, they can release unwanted byproducts such as: dibenzene dioxinbromide and dibenzenofuran bromide.\n\nDuring the last years, there is an increasing concern re. the nocive effects of these materials when they accumulate in the body.\n\nEarlier animal studies show toxic effects of flame retardants: developmental neurotoxicity, hormonal effects and morphological renal and liver changes.\n\nAdditional studies show effects on sex hormones, ano-genital distance, puberty onset and spermatogenesis.\n\nVOC-BTEX: these are aromatic hydrocarbon compounds, widely used in industry. They are a significant part of the air pollutants.\n\nThey have low boiling point and their main way of exposure is via the air. Humans are exposed to them from different sources: cleaning products, paints, solvents, cosmetics, car exhaust gases and cigarettes smoking.\n\nExposure to VOC can increase risk of congenital malformations, neuro-cognitive impairment, asthma and cancer.\n\nDuring combustion, VOC are released into the environment. They may harm many systems in the body: neural, respiratory, reproductive. They also harm the liver and are mutagenic and immunotoxic.\n\nHeavy metals (HM)\n\nHumans are exposed to HM via the air, water or food. At high levels, all HM can harm the lungs. Some of the HM are more harmful than others:\n\nLead -Pb is known for neurological and cognitive harmful effects. Can also harm red blood cells, aminoacids metabolism and other metabolic systems.\n\nMercury -Hg can harm CNS, kidneys and embryos. Short exposure at high levels may harm: lungs, blood tension and heartbeat, digestive system, skin and eyes.\n\nCadmium- Cd causes abortion and preterm deliveries and can cause acidosis. Chromium-Cr: hexavalent chromium may cause skin, eyes and respiratory problems. Chronic exposure can cause cancer.\n\nStudy Plan\n\n1. Trial population\n\n FF will be recruited (200). Exposure levels will be assessed for each participant by means of a detailed questionnaire. Levels of HM, PBDEs and BTEX found in blood and urine will be evaluated against health parameters such as: liver, renal and thyroid function, considering demographical , occupational and health variables (age, tenure, known diseases, eating habits, smoking and drinking.\n2. Data and specimen collection\n\n From each FF, urine and blood (30 cc) samples will be collected and keep refrigerated till arrival into the lab. Samples will be separated and the ones for pollutants analysis will be kept in deep freezer (-80C) till analyzed.\n3. Questionnaires FF will fill up specific questionnaires regarding demography, life-style, life habits during non-working hours. Basic health status, chronic diseases related to thyroid, fertility, psychological problems, both prescription and non-prescription drugs use.\n4. Occupational data General data is routinely collected at the FF station such as work procedures, drills, number of calls.\n\n In addition, personal data will be collected for each FF: tenure, shifts/year, fire calls or other calls/year, task at the station , etc.\n5. Lab tests:\n\nThyroid function: the following will be tested: 4-FT4; TSH; TPO-Ab Tg-Ab at Shamir MC central Lab using SOP Renal function: creatinine and GFR will be measured. Liver function: AST and ALT will be measured\n\nPBDEs will be measured by GC-MS BTEX metabolites will be measured by LC-MS/MS Heavy Metals will be measured by ICP-MS\n\nAs a control group, samples collected in 12/12 trial (NCT03084445) that were not yet analyzed will be used. These samples were collected from men arriving to Shamir MC delivery room with their spouses.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Firefighters', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\* active firefighters\n\nExclusion Criteria:\n\n\\* Women\n\nfirefighters with known liver, renal or thyroid problems'}, 'identificationModule': {'nctId': 'NCT05256212', 'briefTitle': 'Occupational Exposure of Firefighters to Environmental Pollutants', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Occupational Exposure of Firefighters to Environmental Pollutants', 'orgStudyIdInfo': {'id': '0167-17-ASF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'firefighters', 'description': 'firefighters in active service', 'interventionNames': ['Other: exposure to environmental contaminants']}], 'interventions': [{'name': 'exposure to environmental contaminants', 'type': 'OTHER', 'description': 'to measure levels of contaminants in different matrixes', 'armGroupLabels': ['firefighters']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Ẕerifin', 'country': 'Israel', 'facility': 'Assaf Harofeh Medical Center', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}], 'overallOfficials': [{'name': 'Matityahu Berkovitch, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shamir MC'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'from January 22 till December 2022', 'ipdSharing': 'YES', 'description': 'IPD to be shared as needed for QA purposes', 'accessCriteria': 'for QA analysis of reviewers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ben-Gurion University of the Negev', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Research- Clinical Pharmacology and Toxicology', 'investigatorFullName': 'Elkana Kohn', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}