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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Association between occupational solar UVR exposure and melanoma diagnosis.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Be under 18 years of age.
- •Have cognitive impairment that prevents providing reliable answers to the interview or recalling past exposures.
结局指标
主要结局
Association between occupational solar UVR exposure and melanoma diagnosis.
时间窗: 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).
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.
次要结局
- 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.)
- Association between quantitative occupational UVR exposure and melanoma risk score.(Through study completion, up to 24 months.)
研究者
Alberto Modenese
Director of the Occupational Medicine Residency Program, Department of Biomedical, Metabolic and Neural Sciences University of Modena & Reggio Emilia (UniMoRe)
University of Modena and Reggio Emilia