Clinical Research Platform on Decision Making and Clinical Impact of Biomarker-Driven Precision Oncology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- iOMEDICO AG
- 入组人数
- 499
- 试验地点
- 94
- 主要终点
- Overall response rate
研究概览
简要总结
The retrospective cohort study INFINITY will be an instrument to analyze the current practice of precision oncology in the real-world setting. It will provide insight into real-world biomarker-directed treatment of cancer patients not eligible for standard therapies. The study will retrospectively collect medical records' data of patients who received a targeted treatment based on a potentially actionable alteration or biomarker identified by molecular diagnostics. Data of deceased patients will be included. The study will analyze how molecular test results guided clinical decision making. The compiled treatment and outcome data will be a valuable resource to analyze the use and effectiveness of targeted therapy approaches in biomarker-defined and entity-defined subpopulations of cancer patients. These signals might generate new insights and foster progress of targeted cancer treatment. The associated biomarker profiling module aims to set up a decentral biobank for future research on molecular alterations or central re-testing.
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
- •Advanced solid tumors (i.e. locally advanced, inoperable and/or metastatic) or hematologic malignancies not eligible for standard therapy options (i.e. without further treatment options with drugs approved for the specific indication based on the judgement of the treating physician)
- •Started or completed at the documenting study site a non-standard targeted therapy based on an actionable alteration or biomarker identified by molecular diagnostics
- •Results on molecular diagnostics (e.g. tumor genomic or protein expression test) must be available; based on these results the therapy decision was taken
- •Targeted therapy (given as monotherapy or as part of a therapy regimen) must be non-standard at time point of patient registration in the eCRF
- •Age ≥ 18 years
- •Signed and dated informed consent form (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
- •Non-standard targeted therapy was given within a clinical trial
- •The targeted therapy was given in a line of treatment for which it is non-standard (e.g. treatment in first line instead of second line where it is approved); the targeted therapy is however in principle approved for the given entity
- •The targeted therapy was non-standard because a certain prior treatment has not been applied (e.g. targeted therapy is only approved after platin-based treatment but has been given without prior platin-based treatment); the targeted therapy is however in principle approved for the given entity
- •The targeted therapy was non-standard because a different or no chemotherapy back-bone has been applied (e.g. targeted therapy is approved in combination with cisplatin but has been given with oxaliplatin or without chemotherapy backbone); the targeted therapy is however in principle approved for the given entity
结局指标
主要结局
Overall response rate
时间窗: Maximum 5 years
Proportion of patients with CR or PR as best response
次要结局
- Time to treatment failure(Maximum 5 years)
- PFS ratio(Maximum 5 years)
- Patient and Disease Characteristics(maximum 5 years)
- Best overall response(Maximum 5 years)
- Duration of Response(Maximum 5 years)
- Details on molecular diagnostics(Maximum 5 years)
- Clinical decision making(Maximum 5 years (once per targeted therapy))
- Evaluation of selected treatment approach assessed via project specific survey(Maximum 5 years (once per completed targeted therapy))
- Disease Control Rate(Maximum 5 years)
- Time to Response(Maximum 5 years)
- Progression-free survival(Maximum 5 years)
- Overall Survival(Maximum 5 years)