Rare Subtypes of Gastrointestinal Cancers - Real-world Data and Liquid Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Feasibility and translational analysis
研究概览
简要总结
A single-arm prospective observational translational study of biomarkers in patients receiving targeted treatment for rare subtypes of cancer of the Gastrointestinal Tract.
详细描述
In this study, the investigators seek to investigate biological aspects in patients receiving targeted treatment for rare subtypes of cancer of the Gastrointestinal.
The targeted treatment will be given as per standard of care. Translational blood samples will be drawn pre-treatment, before the third cycle of chemotherapy, and hereafter corresponding to the planned imaging during treatment and follow up.
The total cell free DNA will be quantified in all samples. The samples will be analyzed for tumor specific mutations such as the KRAS, BRAF, and NRAS oncogenes, by ddPCR. Circulating tumor DNA will also be identified by hypermethylation markers, and a focused panel of next generation sequencing can be applied. The samples will also be analyzed for immune-related biomarkers.
The investigators expect to include up to 130 patients.
This is a purely observational translational study. Results will be analysed in relation to outcome data.
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
- •Diagnosis of a rare subtype of GI cancer including BRAF V600E mutation, MSI-H, HER2 and others
- •Diagnosis of cancer of the gastrointestinal tract may be made by histo- or cyto-pathology, or by clinical and imaging criteria
- •Planned for targeted treatment
- •Age 18 years or older
- •Able to understand written information
- •Consent to samples for translational research
排除标准
- •Conditions precluding translational blood sampling
- •Another concomitant cancer
结局指标
主要结局
Feasibility and translational analysis
时间窗: 2 years last patient
Investigating potential prognostic and predictive markers for efficacy by molecular characteristics and mutational analysis. We seek to describe the prognostic and predictive value of cfDNA, ctDNA and other markers, e.g. evaluate baseline cf- and ctDNA levels, fluctuations of cf- and ctDNA during treatment and follow up.
次要结局
- Quality of Life by EORTC QLQ-C30(2 years last patient)
- Progression Free Survival(2 years last patient)
- Overall Survival(2 years last patient)
- Response rate(6 months post-treatment)
研究者
Louise Bach Callesen
MD
Aarhus University Hospital