Melanoma of the Skin and Exposure to Solar Ultraviolet Radiation at Work in Modena Territory: a Case-control Study to Promote an Active Search and Prevention of Occupational Diseases Based on Recent INAIL Criteria

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Modena and Reggio Emilia

About this trial

The goal of this observational study is to learn about the link between work-related sun exposure and a specific type of skin cancer called melanoma in people living in the Modena area, Italy.

The main questions it aims to answer are:

* Is there a connection between working outdoors and developing types of melanoma that are linked to long-term sun exposure? * Can we use recent criteria from the Italian workers' compensation authority (Istituto Nazionale per l'Assicurazione contro gli Infortuni sul Lavoro, INAIL) to better identify and report these melanomas as occupational diseases?

Participants in this study will:

* Be patients of the Modena University Hospital Dermatology Clinic who are already undergoing a skin biopsy for a suspected lesion. * Take part in a one-time interview with a trained healthcare worker.

Answer questions about their:

* Job history and specific work locations (to calculate local UVR exposure). * Sun exposure habits at work and in their free/holiday time. * Use of sun protection (e.g., sunscreen, protective clothing). * Use of tanning beds. * Natural skin color and tendency to sunburn (and other elements to determine their specific skin phototype). * Other personal and family health factors.

Researchers will compare two groups:

* Cases: 120 participants who are diagnosed with melanoma after the biopsy. * Controls: 180 participants who screened negative for melanoma but may show another skin condition.

By comparing these groups, researchers aim at better understanding the role of outdoor work as a risk factor for specific melanoma subtypes. For participants diagnosed with a melanoma that is likely linked to their job, the study team will promote its reporting as an occupational disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be a patient of the Dermatology Clinic at the University Hospital of Modena.

Be 18 years of age or older.

Have undergone a dermatological screening for a suspected skin lesion.

Be able to understand and sign an informed consent form in italian language.

Disqualifiers

Be under 18 years of age.

Have cognitive impairment that prevents providing reliable answers to the interview or recalling past exposures.

Trial population

The study population will be selected from the patient cohort attending the Dermatology Clinic of the University Hospital of Modena (Azienda Ospedaliero-Universitaria di Modena), Italy. This clinic serves a large number of citizens from the Modena province and surrounding areas each year, providing a representative sample for investigating skin cancer. Participants will be identified from among those referred to the clinic for the examination and diagnosis of suspicious pigmented skin lesions.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: Cases
Group B: Controls

Trial outcomes

Primary outcomes

1

Association between occupational solar UVR exposure and melanoma diagnosis.

The strength of the association will be measured by calculating the Odds Ratio (OR) for melanoma in participants with a history of occupational solar UVR exposure compared to those without, using multivariate analysis.

Time frame
The Odds Ratio will be calculated and assessed once, at the end of the data collection and analysis phase (at the end of the study).

Secondary outcomes

1

Association stratified by melanoma subtype.

Analysis of the association (measured by Odds Ratios) between occupational solar UVR exposure and specific melanoma subtypes, classified according to the 2018 WHO criteria (e.g., high Cumulative Solar Damage (CSD) subtypes like Lentigo Maligna Melanoma vs. low-CSD subtypes vs. non-solar subtypes).

Time frame
Through study completion, up to 24 months.
2

Association stratified by tumour location.

Analysis of the association (measured by Odds Ratios) between occupational solar UVR exposure and melanoma occurring on chronically sun-exposed body sites versus less exposed or non-exposed sites.

Time frame
Through study completion, up to 24 months.
3

Proportion of melanoma cases reported as occupational diseases.

The number and proportion of melanoma cases that meet the recent INAIL criteria for being reported as an occupational disease due to solar UVR exposure. This applies to outdoor workers diagnosed with a CSD-related melanoma located on photo-exposed body regions.

Time frame
Through study completion, up to 24 months.
4

Quantitative occupational UVR exposure level computation.

The cumulative occupational solar UVR exposure level for each participant with a history of outdoor work will be estimated using the quantitative European job-exposure matrix (JEM) developed by Würtz et al. Exposure will be expressed in Standard Erythemal Doses (SED).

Time frame
Through study completion, up to 24 months.

Other outcomes

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