Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
| Skin Melanoma | Cutaneous Melanoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cases
- description
- Participants in this group are patients recruited from the Dermatology Clinic who have received a new, histopathologically confirmed diagnosis of skin melanoma.
- label
- Controls
- description
- 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.
Primary outcomes (1)
- measure
- 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).
- description
- 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.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (10)
- RESULTDECRETO DEL PRESIDENTE DELLA REPUBBLICA 30 giugno 1965, n. 1124. Testo unico delle disposizioni per l'assicurazione obbligatoria contro gli infortuni sul lavoro e le malattie professionali. GU n.257 del 13-10-1965 - Suppl. Ordinario (Ultimo aggiornamento all'atto pubblicato il 18/11/2023)
- RESULTArmstrong BK, Cust AE. Sun exposure and skin cancer, and the puzzle of cutaneous melanoma: A perspective on Fears et al. Mathematical models of age and ultraviolet effects on the incidence of skin cancer among whites in the United States. American Journal of Epidemiology 1977; 105: 420-427. Cancer Epidemiol. 2017 Jun;48:147-156. doi: 10.1016/j.canep.2017.04.004. Epub 2017 May 3. PMID 28478931
- RESULTElder DE, Bastian BC, Cree IA, Massi D, Scolyer RA. The 2018 World Health Organization Classification of Cutaneous, Mucosal, and Uveal Melanoma: Detailed Analysis of 9 Distinct Subtypes Defined by Their Evolutionary Pathway. Arch Pathol Lab Med. 2020 Apr;144(4):500-522. doi: 10.5858/arpa.2019-0561-RA. Epub 2020 Feb 14. PMID 32057276
- RESULTInail - Sovrintendenza sanitaria centrale: Patrizio Rossi, Grazia Genga Mina. Il melanoma cutaneo professionale da radiazioni solari aspetti d'interesse medico-legale e prevenzionali. ISBN 978-88-7484-825-6
- RESULTChiossi R. Melanoma, 270 diagnosi in un anno. Il 70% scoperto in fase precoce. Gazzetta di Modena, 23/5/2023, available online: https://www.gazzettadimodena.it/modena/cronaca/2023/05/23/news/melanoma-270-diagnosi-in-un-anno-il-70-scoperto-in-fase-precoce-1.100310134
- RESULTPaulo MS, Adam B, Akagwu C, Akparibo I, Al-Rifai RH, Bazrafshan S, Gobba F, Green AC, Ivanov I, Kezic S, Leppink N, Loney T, Modenese A, Pega F, Peters CE, Pruss-Ustun AM, Tenkate T, Ujita Y, Wittlich M, John SM. WHO/ILO work-related burden of disease and injury: Protocol for systematic reviews of occupational exposure to solar ultraviolet radiation and of the effect of occupational exposure to solar ultraviolet radiation on melanoma and non-melanoma skin cancer. Environ Int. 2019 May;126:804-815. doi: 10.1016/j.envint.2018.09.039. Epub 2019 Feb 18. PMID 30792021