Department of Research, Kreftregisteret, Oslo, Norway.
Department of Biostatistics, Universitetet i Oslo Institutt for medisinske basalfag, Oslo, Norway.
BMJ Open. 2019 Feb 20;9(2):e025246. doi: 10.1136/bmjopen-2018-025246.
The incidence of cutaneous melanoma (hereafter melanoma) has increased dramatically among fair-skinned populations worldwide. In Norway, melanoma is the most rapidly growing type of cancer, with a 47% increase among women and 57% among men in 2000-2016. Intermittent ultraviolet exposure early in life and phenotypic characteristics like a fair complexion, freckles and nevi are established risk factors, yet the aetiology of melanoma is multifactorial. Certain prescription drugs may have carcinogenic side effects on the risk of melanoma. Some cardiovascular, antidepressant and immunosuppressive drugs can influence certain biological processes that modulate photosensitivity and immunoregulation. We aim to study whether these drugs are related to melanoma risk.
A population-based matched case-control study will be conducted using nation-wide registry data. Cases will consist of all first primary, histologically verified melanoma cases diagnosed between 2007 and 2015 identified in the Cancer Registry of Norway (14 000 cases). Ten melanoma-free controls per case (on date of case melanoma diagnosis) will be matched based on sex and year of birth from the National Registry of Norway. For the period 2004-2015, and by using the unique personal identification numbers assigned to all Norwegian citizens, the case-control data set will be linked to the Norwegian Prescription Database for information on drugs dispensed prior to the melanoma diagnosis, and to the Medical Birth Registry of Norway for data regarding the number of child births. Conditional logistic regression will be used to estimate associations between drug use and melanoma risk, taking potential confounding factors into account.
The project is approved by the Regional Committee for Medical Research Ethics in Norway and by the Norwegian Data Protection Authority. The study is funded by the Southeastern Norway Regional Health Authority. Results will be published in peer-reviewed journals and disseminated further through scientific conferences, news media and relevant patient interest groups.
全球范围内，白种人群中皮肤黑色素瘤（以下简称黑色素瘤）的发病率显著上升。在挪威，黑色素瘤是增长最快的癌症类型，2000 年至 2016 年间，女性发病率增长 47%，男性发病率增长 57%。早年间歇性暴露于紫外线和白皙的肤色、雀斑和痣等表型特征是已确定的风险因素，但黑色素瘤的病因是多因素的。某些处方药可能会对黑色素瘤的风险产生致癌的副作用。一些心血管、抗抑郁和免疫抑制药物会影响某些调节光敏性和免疫调节的生物过程。我们旨在研究这些药物是否与黑色素瘤风险有关。
将使用全国性登记数据进行基于人群的匹配病例对照研究。病例将包括 2007 年至 2015 年间在挪威癌症登记处（14000 例）诊断的所有首次原发性、组织学证实的黑色素瘤病例。根据性别和病例黑色素瘤诊断年份，从挪威国家登记处匹配每例病例 10 名无黑色素瘤对照（病例诊断日期）。对于 2004 年至 2015 年期间，通过使用分配给所有挪威公民的唯一个人识别号码，病例对照数据集将与挪威处方数据库链接，以获取黑色素瘤诊断前配药信息，并与挪威医学出生登记处链接，以获取生育子女数量的信息。将使用条件逻辑回归来估计药物使用与黑色素瘤风险之间的关联，同时考虑潜在的混杂因素。
该项目已获得挪威地区医学研究伦理委员会和挪威数据保护局的批准。该研究由东南挪威地区卫生当局资助。研究结果将发表在同行评议的期刊上，并通过科学会议、新闻媒体和相关患者利益团体进一步传播。
