Identification, Molecular Epidemiology Angiosarcoma of the Liver France
试验速览
- 阶段
- 不适用
- 入组人数
- 9
- 试验地点
- 12
- 主要终点
- Feasibility of identifying incident cases of angiosarcoma liver from the network NetSarc
研究概览
简要总结
The purpose of this study is to test the feasibility of identifying incident cases of angiosarcoma of the liver from the network NetSarc.
详细描述
The study involves a questionnaire and a one-hour telephone interview.
Consultation:
- Study proposal
- Information and collection of the patient's and/or parent's written consents
- Blood collection (10ml) and urine collection of the patient and parents if applicable
- Delivery of a specific questionnaire and a stamped envelope (with the address of the coordinator's center). If it's about a child patient or an adolescent under 18 years, 3 questionnaires will be given (1 for each parent and 1 for the child).
At home: Filling the questionnaire by the patient and/or the parents, alone at home and return to the coordinator via the given envelope.
During the study: Collect of the initial biopsies used for the hepatic angiosarcoma's diagnostic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient with angiosarcoma of the liver (angiosarcoma immediately multifocal allowed) diagnosed by histology from the start of the study
- •The patient's written Consent
排除标准
- 未提供
研究组 & 干预措施
Patient with angiosarcoma of the liver
Blood and urine collections, questionnaire and telephone interview
干预措施: blood and urine (Biological)
Patient with angiosarcoma of the liver
Blood and urine collections, questionnaire and telephone interview
干预措施: Questionnaire (Behavioral)
Patient with angiosarcoma of the liver
Blood and urine collections, questionnaire and telephone interview
干预措施: Telephone interview (Behavioral)
结局指标
主要结局
Feasibility of identifying incident cases of angiosarcoma liver from the network NetSarc
时间窗: At month 36
Feasibility of identifying incident cases of angiosarcoma of the liver (ASF) from the network NetSarc: number of sheets indicated and returned to the Promoter. 30 cases are expected, the cumulative number of incident cases will be measured over a period of 36 months
次要结局
- Prospective surveillance in France(At month 36)
- Description of occupational risk factors and environmental(At month 36)
- Identification of biomarkers associated with human exposure Environmental old and new to vinyl chloride monomer(At 36 month)
- Assessment of the amount of vinyl chloride monomèredans successive addresses or nearby for cases without occupational exposure identified(At month 36)