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临床试验/NCT04557813
NCT04557813已完成不适用

Registry for Molecular Testing, Treatment and Outcome of Patients With Locally Advanced or Metastatic Solid Tumors Harboring a Fusion of NTRK1, NTRK2 or NTRK3

iOMEDICO AG26 个研究点 分布在 2 个国家目标入组 88 人开始时间: 2020年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
iOMEDICO AG
入组人数
88
试验地点
26
主要终点
Overall response rate

研究概览

简要总结

The objective of this registry is to analyze treatment reality and outcome of patients with locally advanced or metastatic solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3

详细描述

The REALTRK registry will provide data on treatment reality of patients with locally advanced or metastatic solid tumors harboring NTRK1, NTRK2 or NTRK3 gene fusions, thereby generating real world evidence. It will identify factors that influence treatment decisions after receiving the diagnosis of a NTRK (Neurotrophic Tyrosine Receptor Kinase) fusion-positive cancer. All treatment lines administered before and after the molecular diagnosis of a NTRK fusion-positive cancer, irrespective of the type of antineoplastic treatment, will be documented. Data will be assessed at least 36 months per patient (i.e. until 36 months after inclusion of the last patient in the study). This approach will allow a description of TRK fusion protein-targeted therapies and other therapy strategies regarding effectiveness and disease-related symptomology within the limitations of non-randomized studies in terms of comparative analyses. Intra-individual and inter-individual comparisons (for the latter, provided that a sufficient number of patients with a NTRK fusion-positive cancer are not treated with a TRK inhibitor) could be performed.

The associated biomarker profiling module of the REALTRK registry will aim to set up a decentralized biobank for future research on molecular alterations.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Locally advanced or metastatic solid tumor with a documented NTRK gene fusion, based on a validated assay (according to current ESMO recommendations), or the provision of tumor material for central retesting
  • Molecular pathology or molecular diagnostics report with details on NTRK gene fusion testing must be available
  • Aged ≥ 18 years
  • Signed and dated informed consent form (ICF) (only if patient is alive at time of data entry into the project; not applicable for inclusion of deceased patients' data)

排除标准

  • Treatment with a TRK inhibitor prior to Sept 19th, 2019 (Germany) or May 28th, 2020 (Switzerland)
  • Participation in a clinical trial with a TRK inhibitor before or at enrolment (liv-ing patients) or before inclusion (deceased patients)
  • Deceased patients who have explicitly contradicted further use of data

结局指标

主要结局

Overall response rate

时间窗: through study completion, at least 1 year

Proportion of patients with CR or PR as best response

次要结局

  • Patient and disease characteristics(through study completion, at least 1 year)
  • Test methods used for diagnosis of a NTRK fusion-positive cancer(Day 1)
  • Disease control rate(through study completion, at least 1 year)
  • Overall Survival(through study completion, at least average of 1 year)
  • PFS ratio(through study completion, at least 1 year)
  • Event-free survival(through study completion, at least 1 year)
  • Physician-reported factors affecting decision to test for NTRK fusion and treatment decision(Day 1)
  • Treatment reality after diagnosis of NTRK gene fusion(through study completion, at least 1 year)
  • Safety of TRK inhibitor treatments(through study completion, at least 1 year)
  • Physician-reported evaluation of TRK inhibitor therapy(Day 1)
  • Disease-related symptoms(through study completion, at least 1 year)
  • Time to Response(through study completion, at least 1 year)
  • Duration of Response(through study completion, at least 1 year)
  • Progression-free survival(through study completion, at least 1 year)

研究者

发起方
iOMEDICO AG
申办方类型
Industry
责任方
Sponsor

研究点 (26)

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