The First Human Biomonitoring Study in the Marche Region: Assessment of Environmental Exposure and Health Effects

Abstract

Background

As part of the INSINERGIA national project, funded under the National Complementary Plan – “Health, Environment, Biodiversity and Climate” Program, a human biomonitoring study has been launched in several Sites of National Interest (SINs) for environmental remediation. Human biomonitoring represents a key tool for public health and prevention tool, allowing the measurement of environmental contaminants or their metabolites in biological matrices and providing an integrated and directed assessment of individual exposure from multiple sources and pathways. Among the SINs involved the site in Falconara Marittima (Ancona, Italy) is of particular relevance due to its long-standing industrial activities and the potential risk of environmental contamination associated with the sources of pressure present in the area.

Objectives

The study aims to assess exposure to environmental contaminants among residents of the municipality of Falconara Marittima, an area included within the SIN.

Methods

This is a national multicenter cross-sectional study with a low level of intervention. The project involves 13 SINs across 9 Italian regions and plans to recruit approximately 2,600 participants, about 200 subjects for each operational unit. Eligible subjects are adults aged 20–50 years who have continuously resided in the study area for at least five years. Individuals with occupational exposure to the contaminants under investigation and those unable to provide informed participation will be excluded.

For the Falconara Marittima SIN, the population was classified according to environmental exposure levels using a threshold derived from a PM₁₀dispersion model based on pollutant iso-concentration estimates. A balanced stratified random sampling was implemented, with strata defined by sex (male/female), age group (20–34 and 35–50 years), and environmental exposure level (high/low), using data from the regional healthcare beneficiary’s database. To account for expected non-response, additional subjects were randomly selected within each stratum.

Data collection will include questionnaires on sociodemographic characteristics, lifestyle factors, and environmental risk perception. Clinical and anamnestic information, anthropometric and vital parameters, and blood and urine samples will also be collected.

Laboratory analyses will include biomarkers of exposure, such as heavy metals, aromatic and aliphatic compounds, polycyclic aromatic hydrocarbons (PAHs), per- and polyfluoroalkyl substances (PFAS), and polychlorinated biphenyls (PCBs). Biomarkers of effect, including inflammatory cytokines and biochemical-clinical indicators (hematological, metabolic, and endocrine profiles), as well as genetic susceptibility biomarkers (single nucleotide polymorphisms), will also be evaluated.

Descriptive and appropriate group comparison tests will be used to evaluate differences in exposure levels and biological indicators. Associations between exposure and effect biomarkers will be assessed using generalized linear models (GLMs) adjusted for potential confounders, including age, sex, smoking status and other covariates. 

Results

The study is currently in the implementation phase. The organizational framework, site logistics, and biological sample management procedures have been established. Data collection is scheduled for June–July 2026.

Conclusion

The study represents the first integrated human biomonitoring model in the field of environmental-health of this complexity and scope to be developed in the Marche Region. The study is expected to provide valuable evidence for exposure assessment and support the planning of public health interventions in environmentally contaminated areas.