The Use of Genomic Testing and the Resulting Medical Decisions According to Target Identification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 11
- 主要终点
- Types of:molecular profiling methods
研究概览
简要总结
There is no evidence available about which molecular profiling methods are currently used for cancer patients in Austrian clinical practice. The construction of the registry proposed as a completely independent research endeavor, will be helpful for scientific evaluation and the establishment of highly credible data.
详细描述
In the situation of enormous possible beneficial options for patients, health care systems, researchers and companies and the simultaneously present high number of uncertainties, the establishment of an independent registry for patients undergoing any type of comprehensive genomic profiling offers many advantages.
In particular, an overview of the speed of development, the "market penetration", the use of the technology in specific indications (tumor types, stages and in specific situations of unresponsiveness to certain drugs), the frequency by which treatment decisions will definitely follow the result of comprehensive genomic profiling and the reasons for this, the treatment outcome of such patients, the platform technologies applied (in-house (which types), vs. commercial) and the development of these parameters over time and in relation to the development of novel drugs will be analyzed.
The registry proposes to cover the time period from the years 2016 to 2019, which will allow for assessment of both the current and emerging landscape of genomic/molecular testing practice in Austria and effect of molecular profiling on patient care and outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •This registry will include cancer patients for which broad genomic profiling is indicated as assessed by the medical need and as deemed appropriate by the physician, for example
- •cancer with high mutational load and suspicion of regular or frequent formation of neoantigens
- •skin, lung, stomach, esophagus, colorectum, bladder, uterus, cervix, liver, head and neck, kidney, breast
- •lymphoma B-cell
- •any other neoplastic disease where molecular targeting is performed but treatment fails
- •cancer of unknown primary origin (CUP)
- •planned or already carried out comprehensive genomic testing as of Jan 1, 2016 note: this registry will not initially register patients who are tested for only 1-5 mutations by conventional means, but patients undergoing genomic profiling based on NGS)
- •a patient´s signed informed consent
- •Patients ≥ 18 years of age
排除标准
- •Due to the non-interventional design of the registry there are no specific exclusion criteria.
结局指标
主要结局
Types of:molecular profiling methods
时间窗: 3 years
To describe types of:molecular profiling methods used in the Austrian registry centres
Types of cancer, for which comprehensive molecular profiling is used
时间窗: 3 years
To describe types of cancer, for which comprehensive molecular profiling is used
Timing of molecular profiling
时间窗: 3 years
To describe the timing of molecular profiling in relation to stage of the disease (e.g. at diagnosis, after surgery, radiation therapy, after first/second/third/late line)
次要结局
- Number of patients with mutations identified(3 years)
- Quality standards(3 years)
- Treatment decisions(3 years)
- Outcome of treatment(3 years)