Comprehensive Genomic Profiling Combined With Real Life Data of "The German-Registry of Incidental Gallbladder Carcinoma" the CONGENIAL Analysis Sub-study of the GR
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
Multicenter German- Registry of Incidental Gallbladder Carcinoma combining clinical real-world data and comprehensive genomic profiling. The registry collects medical data from clinical observation and molecular data derived from archival tumor tissue samples but does not define any medical intervention nor does it evaluate the efficacy or safety of the treatment decision made by the investigator.
详细描述
In the largest cohort of IGBC patients ever analysed in such a comprehensive approach
- determine the course of patients in this rare kind of cancer
- combine cGP analysis of histological tumor samples with clinical real-life data to get a comprehensive overview on IGBC patients analysed and evaluate data to identify possible further (targeted) treatment possibilities
- analyze potential risk factors associated with gallbladder carcinoma
- assess the frequency of targetable mutations in IGBC
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 incidental gallbladder carcinoma
- •Patient ≥ 18 years old
- •Patient already deceased
- •Available tumor tissue (FFPE block)
排除标准
- •Patient under 18 years of age
结局指标
主要结局
overall survival
时间窗: Through study completion, an average of 2 years
Overall Survival is defined as the time from date of first surgery, to the date of death (due to any cause).
proportion of patients with genomic alterations
时间窗: Through study completion, an average of 2 years
The primary outcome variable of the molecular sub-project is the proportion of patients with actionable genomic alterations, defined as number of patients with actionable mutations divided by the number of patients with completed F1 CDx testing. Additionally, the two-sided 95% exact confidence interval (Clopper-Pearson) will be given.
次要结局
- The proportion of patients with actionable genomic alterations in all patients(Through study completion, an average of 2 years)