An observational study in Skin Melanoma and Cutaneous Melanoma, sponsored by University of Modena and Reggio Emilia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by University of Modena and Reggio Emilia · Observational
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:
Participants in this study will:
Answer questions about their:
Researchers will compare two groups:
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.
This is a monocentric, observational, case-control study conducted at the Dermatology Clinic of the University Hospital of Modena (Azienda Ospedaliero-Universitaria di Modena), Italy.
Background and Rationale:
Skin melanoma is a significant public health concern. While its link to solar ultraviolet radiation (UVR) is established, the specific role of occupational (long-term, cumulative) exposure, as opposed to recreational (intermittent, intense) exposure, is still a subject of detailed investigation. In the period 2008-2014, skin melanoma was included in List 2 (limited probability of occupational origin) of diseases to be mandatorily reported as "occupational" by physicians (Italian law DPR 1124/1965) for the exposure agent "solar radiation". After 2014, it was removed from that list, partly due to evolving scientific evidence suggesting that UV-related malignant melanoma was more strongly related to a pattern of solar ultraviolet radiation exposure typically associated with leisure time activities rather than occupational outdoor activities, especially during childhood and adolescence. Recent classifications by the World Health Organization (WHO) now distinguish melanoma subtypes based on their association with cumulative solar damage (CSD). This is a crucial development, as occupational outdoor activity is a primary factor associated with cumulative sun damage. A joint WHO/International Labour Organization (ILO) meta-analysis found a significantly increased risk for one specific CSD-related subtype, Lentigo Maligna Melanoma, in outdoor workers. In line with this, the Italian National Institute for Insurance against Accidents at Work (Istituto Nazionale per l'Assicurazione contro gli Infortuni sul Lavoro, INAIL) has recently proposed new criteria for recognizing specific CSD-related melanomas as occupational diseases in this worker population.
This study aims to apply these novel criteria in a clinical setting to investigate the association between occupational UVR exposure and CSD-related melanoma subtypes.
Study Objectives:
- The primary objective is to evaluate the association between occupational solar UVR exposure and the risk of developing melanoma, with a specific focus on subtypes related to cumulative solar damage (CSD).
Secondary objectives include:
Study Population and Recruitment:
The study population will consist of patients referred to the Dermatology Clinic for examination of suspicious skin lesions. All enrolled participants will provide written informed consent.
Cases: Approximately 120 adult patients (≥18 years) with a new, histopathologically confirmed diagnosis of cutaneous melanoma.
Controls: Approximately 180 adult patients (≥18 years) who undergo a dermatological screening for a suspicious lesion, but for whom the result of the screening is negative for melanoma. These controls will be matched to cases based on similar age and gender to minimize confounding.
Methods:
Data Collection: After enrolment, all participants (cases and controls) will undergo a single, structured interview conducted by trained healthcare personnel (e.g., resident physicians). The interview will use a detailed questionnaire designed specifically for this study based on a comprehensive literature review.
Questionnaire Content: The questionnaire will collect data on:
Data Management and Analysis:
Quality Assurance:
The study protocol, including the questionnaire and data management plan, will be standardized. Interviewers will receive specific training to ensure consistent data collection. Data entry will include range and consistency checks to ensure quality.
Ethical Considerations:
The study will be conducted after approval from the relevant Ethical Committee of the University Hospital of Modena. Participation is voluntary, and participants may withdraw at any time without affecting their medical care. For outdoor workers diagnosed with a CSD-related melanoma located on sun-exposed skin, the study procedure includes assistance in reporting the disease to INAIL as a potential occupational illness, as per current Italian recommendations.
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.
Exclusion Criteria:
Participants in this group are patients recruited from the Dermatology Clinic who have received a new, histopathologically confirmed diagnosis of skin melanoma.
Participants in this group are patients recruited from the same Dermatology Clinic who have been screened negative for melanoma. These controls are matched to the cases based on similar age and gender.
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).
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.
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.
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.
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.
Individualised melanoma risk score computation.
A quantitative melanoma risk score will be calculated for each participant (both cases and controls) using a risk prediction model developed by Fortes et al. in 2010. This model incorporates known non-occupational risk factors such as skin phototype, hair and eye colour, freckling, family history of melanoma, number of common nevi, and history of sunburns.
Time frame: Through study completion, up to 24 months.
Association between quantitative occupational UVR exposure and melanoma risk score.
Analysis of the relationship between the quantitatively estimated occupational UVR exposure (from the JEM) and the individualised melanoma risk score, to investigate potential interactions or confounding.
Time frame: Through study completion, up to 24 months.
Plan to share: No — The Individual Participant Data (IPD) collected for this study contains detailed and sensitive personal information, including medical histories, occupational records, and lifestyle factors. To ensure the confidentiality and privacy of our participants in compliance with stringent EU and Italian data protection regulations (GDPR), the data will not be made publicly available. The data will be kept securely within the institutional responsibility of the University of Modena and Reggio Emilia for the purposes outlined in this protocol.
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University of Modena and Reggio Emilia