Augsburg Longitudinal Plasma Study (ALPS) to Study Liquid Biopsy (LBx) as a Tool for Diagnostic Support, Assessment of Disease Progression, and Identification of Mutations During Disease Course in Patients With Solid Neoplasms Receiving Palliative Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Concordance between TBx and LBx at disease progression
研究概览
简要总结
A prospective observational trial of patients with metastatic cancer of various entities which aims at both clarifying the significance of liquid biopsy and establishing a foundation for translational research.
详细描述
ALPS is a prospective observational trial to assess liquid biopsy as diagnostic tool in patients with various metastatic neoplasms. Liquid biopsy will be correlated not only with the tissue biopsy, but also to imaging modalities and classical tumor markers. In addition, the study aims to investigate clonal heterogeneity and evolution of different cancers during patient treatment courses. A third aspect of the study is to survey and assess patients' knowledge about biomarkers and personalized medicine in general and about liquid biopsy as a new diagnostic tool.
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
- •Written informed consent
- •Age ≥ 18 years
- •Histopathologically confirmed metastatic or locally advanced cancer
- •No curative treatment options, except for germ cell tumors
- •Written Agreement to be followed up at Augsburg University Medical Center
- •Signed written informed consent for the Biobank Augsburg (Biobank-A)
- •Willing to undergo treatment according to standard of care
- •Availability or anticipated availability of tumor tissue at time point of inclusion
- •Anticipated life expectancy of at least 3 months at time point of trial inclusion
排除标准
- •Psychological condition that would preclude informed consent
- •Additional tumor treatment between acquisition of tumor tissue and trial inclusion
结局指标
主要结局
Concordance between TBx and LBx at disease progression
时间窗: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Concordance between TBx and LBx at disease progression with TBx as reference method based on PPA (positive percent agreement) and NPA (negative percent agreement)
Correlation of tumor mutations between tissue biopsy (TBx) and liquid biopsy (LBx) at diagnosis
时间窗: through study completion, an average of 3 years
Correlation of tumor mutations between TBx and LBx at diagnosis with TBx as reference method based on PPA (positive percent agreement) and NPA (negative percent agreement)
次要结局
- Investigation of tumor heterogeneity as a prognostic marker(through study completion, an average of 3 years)
- Correlation of known and potential oncogenic drivers in LBx with OS(through study completion, an average of 3 years)
- Correlation of known and potential oncogenic drivers in LBx with DCR(through study completion, an average of 3 years)
- Role of a single numeric value (Shannon-Heterogeneity Index) at diagnosis as a surrogate marker for tumor heterogeneity(through study completion, an average of 3 years)