The Platform for Analyzing Targetable Tumor Mutations Network (Main-study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 565
- 试验地点
- 31
- 主要终点
- Frequency of targetable mutations in gastrointestinal cancer patients
研究概览
简要总结
The PLATON Network study is designed to elevate personalized therapy based on genomic tumor profiles in gastrointestinal cancer patients. Hereby, PLATON's study-design focuses on the patient's tumor molecular profiling. Within the network a web application will be developed to link clinical investigators and information on study sites, cancer patients and genetic alteration data, as well as available clinical trials at PLATON's study sites.
详细描述
The PLATON Network is established as permanent open, multicenter, prospective, cohort study of patients with gastrointestinal cancer. The study design includes a study-specific biobank and a shared platform infrastructure for associated sub-studies and analysis projects.
Within PLATON results of genetic tests of different research projects like the PLATON pilot-study (NCT04484636) as well as Next-generation deep sequencing (NGS) according to local protocols will be documented - compiling genomic tumor-profiles including tumor mutational burden (TMB) and microsatellite instability (MSI).
The PLATON Network infrastructure is designed to increase the likelihood of treating the patients with an individualized therapy in available clinical studies. Therefore, molecular profiling must go hand in hand with inter-linking physicians and increasing inter-centre transparency. The feasibility of this approach will be tested in the PLATON Network, keeping in mind the vision of cancer patients receiving the best available, scientifically founded, biomarker-based care, tailored to his or her individual needs.
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
- •Histologically confirmed diagnosis of hepatocellular carcinoma or intra- cholangiocarcinoma, extrahepatic cholangiocarcinoma or gallbladder carcinoma or pancreatic ductal adenocarcinoma or esophagogastric adenocarcinoma in the advanced setting (adjuvant or neoadjuvant therapy is allowed if completed 6 months prior to enrolment) and no local curative therapy available
- •Standard first line therapy is planned, or patient is currently receiving first-line therapy
- •Available tumor-genomic profile ( ≥50-gene panel assay; approved and assessed by central review), unless central tumor genomic profiling is done within a sub-study
- •Life expectancy ≥ 6 months
排除标准
- •Not able to understand all implications of study participation
- •No written informed consent
- •Age < 18 years
研究组 & 干预措施
EC/GC (Oesophagogastric cancer)
Oesophagogastric cancer patients with NGS based molecular tumor profiling
HCC (Hepatocellular cancer)
Hepatocellular cancer patients with NGS based molecular tumor profiling
CCA/GBCA (Intra-, extrahepatic cholangiocellular carcinoma or gallbladder cancer)
Intra-, extrahepatic cholangiocellular carcinoma or gallbladder cancer patients with NGS based molecular tumor profiling
PanCa (Pancreatic cancer)
Pancreatic cancer patients with NGS based molecular tumor profiling
结局指标
主要结局
Frequency of targetable mutations in gastrointestinal cancer patients
时间窗: annual interim-analysis (1 year)
Relative frequency of targetable mutations computed as the number of patients who harbor at least one mutation divided by the number of total patients in the analyzed patient population
Tumor mutations and their impact on treatment decisions in gastrointestinal cancer patients
时间窗: annual interim-analysis (1 year)
Number of received therapies in or out accordance to genomic profiles
次要结局
- QoL via EORTC QLQ-HCC18 questionnaire in genetically defined cohorts of HCC patients(annual interim-analysis (1 year))
- QoL via EORTC QLQ-C30 questionnaire in genetically defined cohorts in gastrointestinal cancer patients(annual interim-analysis (1 year))
- QoL via EORTC QLQ-BIL21 questionnaire in genetically defined cohorts of CCA and GBCA patients(annual interim-analysis (1 year))
- Overall survival (OS) in genetically defined cohorts in gastrointestinal cancer patients(annual interim-analysis (1 year))
- QoL via EORTC QLQ-PAN26 questionnaire in genetically defined cohorts of PDCA patients(annual interim-analysis (1 year))
- QoL via EQ-5D-5L questionnaire in genetically defined cohorts in gastrointestinal cancer patients(annual interim-analysis (1 year))
- QoL via EORTC QLQ-STO22 questionnaire in genetically defined cohorts of EC/GC patients(annual interim-analysis (1 year))