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临床试验/NCT05730686
NCT05730686尚未招募不适用

FibroLamellar Carcinoma: an International Registry Study

Imperial College London0 个研究点目标入组 200 人开始时间: 2023年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
To describe the natural history and clinical outcomes of patients with Fibrolamellar carcinoma of the liver

研究概览

简要总结

Fibrolamellar Hepatocellular Carcinoma (FLC) is a rare (0.05 per 100,000) subtype of primary liver cancer which predominantly affects younger patients, median age of diagnosis 22-23 years. In patients with advanced stage disease the prognosis is poor, and even with aggressive surgery the 5 year survival is less than 50%.

Due to the very low incidence of FLC clinical trials are limited, and as these patients are excluded from most clinical trials there is a lack of consensus on the optimal systemic therapy to employ in this population group.

There are a number of chemotherapy compounds that have been investigated although these are single-institutional case series and/or registry-based studies. The majority of published registry studies are based in the United States hence it is important to describe the patterns of treatment in Europe which has different regulatory approvals for access to therapeutics. Our aim is to run a European multisite registry study detailing the clinical course of >100 patients with FLC that have received systemic therapy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologic confirmed diagnosis of FLC
  • Written informed consent will be required for the prospective cohort
  • Adults of >18 years of age

排除标准

  • Any non- histologic confirmed diagnosis of FLC
  • Participants with insufficient clinical/ follow up data

结局指标

主要结局

To describe the natural history and clinical outcomes of patients with Fibrolamellar carcinoma of the liver

时间窗: 2 years

The following data will be outcomes of interest in this study: treatments received including compliance and tolerability, survival (overall and progress free survival), clinicopathological outcomes. Survival outcomes, response rates

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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