Melanoma of the Skin and Exposure to Solar Ultraviolet Radiation at Work in Modena Territory: a C… (NCT07251335) | Clinical Trial Compass
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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
Italy300 participantsStarted 2025-07-07
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Be under 18 years of age.
* Have cognitive impairment that prevents providing reliable answers to the interview or recalling past exposures.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is specifically looking at whether outdoor work and sun exposure on the job may be linked to melanoma, would my own work history — such as time spent working outside — be relevant information worth discussing in the context of this trial?
2This appears to be an observational case-control study rather than a treatment trial, so does participating involve any new treatments or procedures, or is it mainly about answering questions and providing information about my occupational history?
3The study is connected to INAIL criteria, which relates to recognizing occupational diseases in Italy — could my melanoma potentially be considered work-related based on my job history, and what would that mean for my care or any rights I might have?
4Since this study is in the Modena territory specifically, is this something that would only be relevant if I was diagnosed and treated in that region, or could my case still contribute useful information?
5Given that I'm already dealing with a melanoma diagnosis, how would my doctor weigh the value of participating in this kind of research study against focusing entirely on my treatment plan right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Association between occupational solar UVR exposure and melanoma diagnosis.
Timeframe: 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).