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