肉瘤是罕见的结缔组织肿瘤。由于诊断困难和各种组织学亚型(超过80种亚型),肉瘤的确切总体发生率尚不清楚。然而,肉瘤发病率的明显增加表明了环境原因,如杀虫剂。除了一些特定的因素(即,电离辐射,氯乙烯,二恶英和遗传易感性)关于肉瘤病因的科学知识很少且不一致。法国是一个特别合适的国家,可以开展一项研究,调查由于法国组织对肉瘤患者的治疗和护理而导致的肉瘤发生的原因,它是高度结构化的,围绕着国家专家网络。SARcomas(ETIOSARC)项目的主要目标是研究生活方式的作用,基于多中心人群的病例对照研究中成人肉瘤发生的环境和职业因素。
病例将是法国15个地区的所有事件患者(18岁以上),在3年内由一般人群癌症登记处和/或肉瘤患者护理参考中心覆盖,纳入开始日期为2019年2月至2020年1月,并在组织学上通过第二次诊断审查确认。两个对照将按性别单独匹配,年龄(5岁组)和居住地,并从选民名册中随机选择。标准化问卷将由训练有素的面试官管理,以收集有关职业和居住历史的信息,人口和社会经济特征和生活方式因素。面试结束时,将系统地提出唾液样本。这项研究将允许验证或确定已经怀疑的肉瘤危险因素,如苯氧除草剂,并提出新的假设,以增加我们对致癌过程中遗传和环境贡献的理解。
本研究由法国国立卫生与医学研究所(识别号C17-03)推动。这项研究获得了法国国家伦理委员会(CPPSudMéditerranneI)的批准(标识号18-31)和法国数据保护局(CNIL)的批准(标识号918171)。这项研究的结果将发表在国际同行评审期刊上。技术附录,收集数据完成后,Dryad存储库中将提供统计代码和数据集。
NCT03670927。
Sarcomas are rare tumours of connective tissue. The exact overall incidence of sarcomas is unknown due to diagnostic difficulties and the various histological subtypes (over 80 subtypes). However, the apparent increasing incidence of sarcomas suggests environmental causes such as pesticides. Except for some specific factors (ie, ionising radiation, vinyl chloride, dioxin and genetic predispositions) the scientific knowledge on the aetiology of sarcomas is sparse and inconsistent. France is a particularly appropriate country to set up a
study investigating the causes of sarcoma occurrence due to the French organisation in treatment and care of sarcoma patients, which is highly structured and revolved around national expert networks. The main objective of the ETIOlogy of SARcomas (ETIOSARC) project is to
study the role of lifestyle, environmental and occupational factors in the occurrence of sarcomas among adults from a multicentric population-based case-control
study.
Cases will be all incident patients (older than 18 years) prospectively identified in 15 districts of France covered by a general population-based cancer registry and/or a reference centre in sarcoma\'s patient care over a 3-year period with an inclusion start date ranging from February 2019 to January 2020 and histologically confirmed by a second review of the diagnosis. Two controls will be individually matched by sex, age (5 years group) and districts of residence and randomly selected from electoral rolls. A standardised questionnaire will be administered by a trained interviewer in order to gather information about occupational and residential history, demographic and socioeconomic characteristics and lifestyle factors. At the end of the interview, a saliva sample will be systematically proposed. This study will permit to validate or identify already suspected risk factors for sarcomas such as phenoxyherbicides, chlorophenol and to generate new hypothesis to increase our understanding about the genetic and environmental contributions in the carcinogenicity process.
The present study is promoted by the French National Institute of Health and Medical Research (identification number C17-03). This
study received National French Ethic committee (CPP Sud Méditerrannée I) approval (identification number 18-31) and French Data Protection Authority (CNIL) approval (identification number 918171). Results of this
study will be published in international peer-reviewed journals. Technical appendix, statistical code and dataset will be available in the Dryad repository when collection data are completed.
NCT03670927.