Clinical trial

Biological Signatures (Proteomics, Metabolomics and Genotoxicity) Associated With Occupational Exposure to PAH Mixtures and Relation With Exposure Biomarkers: Support for the Derivation of Biological Limit Values

Name

38RC22.0219

Description

This research project aims at better understanding the early biological effects resulting from occupational exposure to complex Polycyclic Aromatic Hydrocarbon (PAH) mixtures. Current biomarkers used as part of biomonitoring campaigns are biomarkers of exposure, not numerous and poorly related to health effects. The aim of this study is thus to improve our understanding of biological consequences of such exposures, both in terms of proteins deregulation, metabolism deregulation and genotoxicity.

Trial arms

Trial start

2023-04-25

Estimated PCD

2025-10-01

Trial end

2025-10-01

Status

Recruiting

Treatment

Characterization of early biological effects following exposure to PAHs

Biological samples collected in period of exposure and after holidays

Arms:

Subjects occupationally exposed to PAHs

Size

100

Primary endpoint

Deregulation of blood proteins expression due to exposure to PAHs

up to 6 months between both periods of study

Deregulation of blood metabolites expression due to exposure to PAHs

up to 6 months between both periods of study

Frequency of micronuclei measured due to exposure to PAHs

up to 6 months between both periods of study

Eligibility criteria

Inclusion Criteria: * Subjects ages 18 years or more * Subjects occupationally exposed to PAHs since more than 3 months * Having signed the informed consent * recruited by the occupational health service Exclusion Criteria: * Obesity (BMI\>30) * Subjects suffering cancers or metabolic diseases (diabetes, dyslipidemia, amino-acid diseases, renal or hepatic impairment) at the onset of the study. * Subjects taking medications related to the above diseases at the onset of the study.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2024-06-03

1 organization

1 product

3 indications

Organization

University Hospital of Grenoble

Product

Indication

Indication

Indication