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临床试验/NCT03963544
NCT03963544已完成不适用

Patterns of Care and Outcomes of Patients With METAstatic Gastrointestinal Stromal Tumors (GIST) in a Real-life Setting: the METAGIST Observational Study

Institut Bergonié1 个研究点 分布在 1 个国家目标入组 492 人开始时间: 1990年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
492
试验地点
1
主要终点
Time to Next Treatment (TNT)

研究概览

简要总结

Gastro intestinal stromal tumors (GIST) are rare mesenchymal tumors of the gastrointestinal tract characterized by somatic mutations in the gene encoding the KIT or the PDGFR alpha protein1. Treatment of localized forms relies on adequate surgery without tumor spillage and systemic treatment with imatinib according to risk of relapse defined by localization, tumor size and mitotic count, as well as mutational status. Advanced and relapsing forms are currently treated with oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR such as Imatinib, Sunitinib and Regorafenib. Over two decades significant changes in drug discovery have impacted treatment strategies, notably via patient's access to various clinical trials. The use of focal treatments such as surgery or interventional radiology with mini invasive procedure of oligometastasis is also being proposed in some cases.

There is no precise data on patterns of sequential treatments used, especially proportions of patients with metastatic GIST eventually benefiting from access to a clinical trial or a focal treatment strategy in the course of their disease, and their results in terms of survival on a real life national level.

Using the French sarcoma Group national database we aim at describing treatments strategies proposed patients with metastatic GIST in the real life setting.

Objectives include : (i) Description of clinico-biological profiles, patterns of care and modalities of treatment of patients with metastatic GIST in a real-life national setting and (ii) evaluation of patients outcome in terms of time to next treatment (TNT) and survival

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • patients ≥ 18 years old
  • with a diagnosis of metastatic Gastrointestinal Stromal Tumor (metastatic at diagnostic or metastatic relapse)
  • From 1990 to 2018

排除标准

  • 未提供

结局指标

主要结局

Time to Next Treatment (TNT)

时间窗: 10 years

time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first.

Overall Survival (OS) Time

时间窗: 10 years

the interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death.

次要结局

  • Treatment With a Systemic Therapy(At diagnosis of metastatic disease)
  • Proportion of Participants Included in a Clinical Trial(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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