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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

NCT07251335 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-12-18

No results posted yet for this study

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

Sponsors & Collaborators

  • University of Modena and Reggio Emilia

    lead OTHER

Principal Investigators

  • Alberto Modenese, MD. PhD · University of Modena and Reggio Emilia

  • Francesca Farnetani, MD · University of Modena and Reggio Emilia

  • Paola Ferri, MSc · University of Modena and Reggio Emilia

  • Sergio Rovesti, MD · University of Modena and Reggio

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-07
Primary Completion
2027-04-30
Completion
2027-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07251335 on ClinicalTrials.gov