AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 3
- 主要终点
- NGS
研究概览
简要总结
National, retro- and prospective, observational, multicenter clinical research platform to connect clinical and genomic data of patients with advanced (locally advanced, inoperable, or metastatic) solid tumors (excluding NSCLC, SCLC, and mesothelioma) with results from multi-gene next-generation sequencing (NGS) panels (>30 genes)
详细描述
The AIO-BNHO CONNECT research platform is a clinic-genomic database collecting data on NGS results and corresponding clinical outcomes in patients with advanced solid tumors (excluding NSCLC, SCLC, and mesothelioma). Data of deceased patients will be included. The platform will provide insight into the current state of precision oncology in Germany by compiling real-world data encompassing a broad spectrum of care providers including but not limited to practice-based oncologists, community hospitals, and university hospitals. The platform also comprises a decentral tissue repository with clinically annotated tumor specimens retrieved within routine clinical care that can be used in future collaborative research projects.
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
- •Diagnosis of advanced (i.e., locally advanced, inoperable, or metastatic) solid tumor, ineligible for curative surgery and/or curative systemic therapy
- •Available results of commercial or non-commercial RNA- and/or DNA-based multi-gene NGS panels with >30 genes analyzed; for non-commercial panels a list of all tested genes and multiple gene biomarkers (e.g., tumor mutational burden (TMB), microsatellite status) must be provided
- •Age ≥ 18 years
- •Signed and dated informed consent form (not applicable for inclusion of deceased patients)
排除标准
- •Diagnosis of NSCLC/SCLC (C34) or mesothelioma (C45)
- •NGS results older than two years at the date of patient inclusion
结局指标
主要结局
NGS
时间窗: 3 years
Genomic alterations identified by multi-gene NGS panels
Molecular tumorboard utilization
时间窗: 3 years
Proportion of patients who's case was discussed in a Molecular tumorboard
Treatment reality after NGS analysis
时间窗: 3 years
Proportion of patients who received at least one targeted therapy based on NGS results, who exclusively received therapies other than targeted therapies based on NGS results or who did not receive any therapy
Progression-free survival (PFS)
时间窗: 3 years
Progression-free survival from start of targeted therapy based on NGS results
Overall survival
时间窗: 3 years
Overall survival from start of targeted therapy based on NGS results
PFS ratio
时间窗: 3 years
PFS interval associated with targeted therapy(ies) administered after NGS analysis divided by the time to progression (TTP) interval associated with the last prior treatment(s)
Molecular tumorboard
时间窗: 3 years
Descriptive analysis of MTB-based therapy recommendations, their implementation rate and reasons for non-implementation
Overall response rate
时间窗: 3 years
Overall response rate of targeted therapy based on NGS results
次要结局
未报告次要终点