Research Collaboration for a Precision Oncology Program (POP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Utility of RWD matching report as assessed by the questionnaire
研究概览
简要总结
The Precision Oncology Program (POP) research collaboration aims to help generate information about the individual tumour biology for patients with advanced malignancies, using innovative biotechnologies and patient profile comparison ("matching") against specific databases (Real-world data, RWD) and to inform about potential benefit, or lack of benefit, from a given treatment.
详细描述
This is an observational clinical project. The aim of this research collaboration is to establish processes to advance precision oncology within the clinical routine. POP generates information about individual tumour for patients with advanced cancers using innovative molecular technologies and patient profile comparison ("matching") against specific public and non-public databases with the aim to support clinical decision-making (therapy prediction).
The POP report will summarize the clinically-relevant findings from the following tests and procedures:
A. Routine genetic testing:
FMI (routine genetic testing) Comprehensive tumour genotyping which includes alterations in cancer-relevant genes and the following parameters: Tumor mutational burden (TMB), Loss of heterozygosity (LoH), Microsatellite Instability (MSI).
B. POP-specific additional testing:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Signed informed consent
- •In the case of deceased persons: signed general consent
- •All patients with the diagnosis of a solid tumour including adenocarcinoma, squamous cell carcinoma, neuroendocrine carcinoma, sarcoma, etc
- •ECOG-performance status 0-2, if applicable
- •Willing and able to understand all project related procedures, including transfer of coded (i.e. pseudonymised) or anonymized clinical data to external partners (e.g. Roche), if applicable
排除标准
- •Patients with the diagnosis of blood cancer.
结局指标
主要结局
Utility of RWD matching report as assessed by the questionnaire
时间窗: From date of enrollment, assessed up to 2 years
1. Is the Report used to identify imminent or future treatment options? 2. How has the Report changed your confidence in the primary decision? 3. Does the Report support the primary therapy decision? 4. Is the relevant information in the Report non supportive of the Resources used or the primary therapy decision? 5. What Resources did you use for the primary therapy decision? 6. How useful was the Report to decide on the secondary therapy decision? 7. Which features of the Report were used for the secondary therapy decision? 8. Could you have gathered the information in the Report used for the secondary treatment decision in less than 15 min? 9. Did the Report provide unique information on personalizing future treatment regimens?
Utility of the IMC report as assessed by the questionnaire
时间窗: From date of enrollment, assessed up to 2 years
1. Is the Report used to identify imminent or future treatment options? 2. How has the Report changed your confidence in the primary decision? 3. Does the Report support the primary therapy decision? 4. Is the relevant information in the Report non supportive of the Resources used or the primary therapy decision? 5. What Resources did you use for the primary therapy decision? 6. How useful was the Report to decide on the secondary therapy decision? 7. Which features of the Report were used for the secondary therapy decision? 8. Could you have gathered the information in the Report used for the secondary treatment decision in less than 15 min? 9. Did the Report provide unique information on personalizing future treatment regimens?
次要结局
- Number of POP reports provided(through study completion, an average of 1 year)
- Classification of Treatment Options(through study completion, an average of 1 year)
研究者
Andreas Wicki
Professor
University of Zurich