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

NCT07251335 | Recruiting

• 2 other identifiers: FAR_438_2024GRANT_NUMBER: PRJ-0532 FAR2024
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Melanoma; Cutaneous Melanoma

Keywords

Skin melanoma; Cutaneous Melanoma; Occupational Exposure; Solar Ultraviolet Radiation; Outdoor Workers; Case-Control Study; Occupational Disease; Skin Cancer; Cumulative Sun Damage; Lentigo Maligna Melanoma; Occupational Health; Dermatology; Italy; Occupational Medicine

Outcome Measures

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.

  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 (6)

• Association stratified by melanoma subtype.

  Through study completion, up to 24 months.

• Association stratified by tumour location.

  Through study completion, up to 24 months.

• Proportion of melanoma cases reported as occupational diseases.

  Through study completion, up to 24 months.

• Quantitative occupational UVR exposure level computation.

  Through study completion, up to 24 months.

• Individualised melanoma risk score computation.

  Through study completion, up to 24 months.

Study Arms (2)

Cases

Participants in this group are patients recruited from the Dermatology Clinic who have received a new, histopathologically confirmed diagnosis of skin melanoma.

Controls

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Be under 18 years of age.
• Have cognitive impairment that prevents providing reliable answers to the interview or recalling past exposures.

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

Dipartimento di Scienze Biomediche, Metaboliche e Neuroscienze

Modena, Mo, 41122, Italy

RECRUITING

Related Publications (10)

• DECRETO 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)

  RESULT

• Armstrong 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 RESULT

• Elder 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 RESULT

• Inail - 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

  RESULT

• Chiossi 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

  RESULT

• Paulo 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 RESULT

• Gobba F, Dall'Olio E, Modenese A, De Maria M, Campi L, Cavallini GM. Work-Related Eye Injuries: A Relevant Health Problem. Main Epidemiological Data from a Highly-Industrialized Area of Northern Italy. Int J Environ Res Public Health. 2017 Jun 6;14(6):604. doi: 10.3390/ijerph14060604.

  PMID: 28587288 RESULT

• Modenese A, Loney T, Ruggieri FP, Tornese L, Gobba F. Sun protection habits and behaviors of a group of outdoor workers and students from the agricultural and construction sectors in north-Italy. Med Lav. 2020 Apr 30;111(2):116-125. doi: 10.23749/mdl.v111i2.8929.

  PMID: 32352425 RESULT

• Modenese A, Farnetani F, Andreoli A, Pellacani G, Gobba F. Questionnaire-based evaluation of occupational and non-occupational solar radiation exposure in a sample of Italian patients treated for actinic keratosis and other non-melanoma skin cancers. J Eur Acad Dermatol Venereol. 2016 Apr;30 Suppl 3:21-6. doi: 10.1111/jdv.13606.

  PMID: 26995019 RESULT

• Wurtz ET, Pugdahl K, Fenger-Gron M, Berglind IA, Cherrie MPC, Dahlman-Hoglund A, Grandahl K, Macan J, Modenese A, Noto H, Solovieva S, Straif K, Wittlich M, Connemann S, Heepenstrick T, Philipsen PA, Westerhausen S, Ge CB, Hansen J, Peters CE, Mehlum IS, Schlunssen V, Kolstad HA. A quantitative solar ultraviolet radiation job-exposure matrix for Europe. Ann Work Expo Health. 2025 Apr 24;69(4):415-428. doi: 10.1093/annweh/wxaf011.

  PMID: 40056460 RESULT

MeSH Terms

Conditions

Melanoma; Occupational Diseases; Skin Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alberto Modenese, MD. PhD

  University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

• Francesca Farnetani, MD

  University of Modena and Reggio Emilia

  STUDY CHAIR

• Paola Ferri, MSc

  University of Modena and Reggio Emilia

  STUDY DIRECTOR

• Sergio Rovesti, MD

  University of Modena and Reggio

  STUDY DIRECTOR

Central Study Contacts

Alberto Modenese, MD, PhD

CONTACT

+39 059 205 5461; alberto.modenese@unimore.it

Angela Contri, PhD

CONTACT

+39059 205 5463; angela.contri@unimore.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Occupational Medicine Residency Program, Department of Biomedical, Metabolic and Neural Sciences University of Modena & Reggio Emilia (UniMoRe)

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)