Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 41
- 主要终点
- Overall Survival
研究概览
简要总结
This registry will make it possible to describe real life management of patients with rare actionable fusions and to better understand these cancers. In addition of clinical data from the medical files, a quality of life questionnaire (QLQ-C30) will be complete at inclusion, at each new treatment and then every 6 months. The patients will be followed for a period of at least 2 years after the inclusion.
This TRacKING registry is a European collaborative tool to improve the management of patients with actionable fusions, by sharing of data from rare tumor indications.
详细描述
- Administrative opening of the center
- Routine identification of a patients harboring a rare actionable fusion
- Patient's inclusion
- Signature of written informed consent,
- Declaration by the physician to the coordinating center (using the "Physician declaration" form)
- Completion of the QLQ-C30 questionnaire (at inclusion, at each new treatment and then every 6 months).
- Collection of retrospective and prospective data into the e-CRF by a local CRA using patients' medical files.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Patient with histologically-confirmed cancer
- •Patient harboring a rare actionable fusion (see Appendix 1),
- •Availability of clinical and demographic data, information on treatment and clinical outcome.
- •Adult, ≥18 years old,
- •Patient should understand, sign and date the written voluntary informed consent form.
排除标准
- 未提供
结局指标
主要结局
Overall Survival
时间窗: 2 years
To describe the survival rate of patients with solid cancers harboring a NTRK fusion or other rare actionable fusion in real-life practice, according to overall survival (OS)
次要结局
- Incidence of long-term responders(up to 48 months)
- Quality of life of patient(After 6, 12, 18, 24, 30, 36, 42, 48 months)
- Incidence of long-term responders for patient treated by fusion-targeting treatments(up to 48 months)
- Safety : Frequency of adverse reaction (for treatment targeting a fusion)(up to 48 months)
- Progression Free Survival (PFS)(after 6, 12 and 24 months)
- PFS for patient treated by fusion-targeting treatments(After 6, 12, 24 months of treatment by fusion targeting treatments)
- Safety : Severity of adverse reaction (for treatment targeting a fusion)(up to 48 months)
- Time to relapse(up to 48 months)
- Time to relapse for fusion-targeting treatments(up to 48 months)
- Overall survival for patient treated by fusion-targeting treatments(2 years)
- Safety : Nature of adverse reaction (for treatment targeting a fusion)(up to 48 months)
- Management of patient with actionable fusion(up to 48 months)
- Quality of life of patient treated by fusion-targeting treatments(After 6, 12, 18, 24, 30, 36, 42, 48 months of fusion-targeting treatments)