Liquid Biopsies in Esophageal Adenocarcinoma: Barrett's Esophagus and Esophageal Adenocarcinoma, Searching for Reliable Diagnostic RNA Plasma-based Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Identification of plasma biomarkers (micro RNAs) for early detection of esophageal adenocarcinoma
研究概览
简要总结
This study is designed to perform a explorative search of the transcriptome to detect new circulating diagnostic sensitive and specific biomarkers in patients with Barrett's esophagus or esophageal adenocarcinoma.
详细描述
By developing new tools for risk-assessing of Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) in a population at risk, the investigators expect that diagnosis can be done in an earlier stage resulting in an improved 5-year survival. A proof-of-concept RNA profiling study will be done in 20 BE and EAC patients where 2 biomaterials (tissue and plasma) and 2 RNA biotopes (micro RNA and messenger RNA) will be compared. Previously validated methodology on small RNA and messenger RNA capture sequencing on both tissue and plasma will be used to obtain high-quality data. Differential expression analysis will be done on tissue and plasma sample data. Additional in-depth data-mining will be done, amongst other focusing on structural information encoded in the transcriptome and building a multifeature classifier. These findings will be validated in a large validation cohort, followed by development of a clinical-grade quantitative Polymerase Chain Reaction (qPCR) test, ready for testing in an independent cohort.
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
- 是
入选标准
- •Barrett's Esophagus with length > 3cm OR esophageal adenocarcinoma histologically proven
- •Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent
- •Age over 18 years
- •No other concurrent malignant disease
- •No inclusion in other clinical trials interfering with the study protocol
- •No concurrent chronic systemic immune or hormone therapy, except neoadjuvant chemotherapy
- •Absence of any severe organ insufficiency
- •No pregnancy or breast feeding
- •Written informed consent
排除标准
- •Pregnancy or breast feeding
- •Active bacterial, viral or fungal infection
- •Parenchymal liver disease (any stage cirrhosis)
- •High risk of bleeding during biopsy (anticoagulants, esophageal varices)
- •Esophageal squamous cell carcinoma
- •Helicobacter pylori positive at the time of biopsy sampling
- •Radiofrequency ablation of the oesophagus
- •Psychiatric pathology capable of affecting comprehension and judgement faculty
结局指标
主要结局
Identification of plasma biomarkers (micro RNAs) for early detection of esophageal adenocarcinoma
时间窗: 4 years
Identification of micro RNAs in plasma and tissue of patients with (non-)dysplastic Barrett's esophagus and EAC that are differentially abundant, compared to healthy plasma (healthy volunteers) or healthy tissue (patient-matched healthy esophagus biopsies).
Identification of plasma biomarkers (messenger RNAs) for early detection of esophageal adenocarcinoma
时间窗: 4 years
Identification of messenger RNAs in plasma and tissue of patients with (non-)dysplastic Barrett's esophagus and EAC that are differentially abundant, compared to healthy plasma (healthy volunteers) or healthy tissue (patient-matched healthy esophagus biopsies).
Identification of biomarkers (messenger RNAs) for therapy response prediction
时间窗: 2 years
Identification of a set of messenger RNAs that change during treatment (using longitudinally collected plasma samples) and that separate responders from non-responders to neo-adjuvant radiochemotherapy.
次要结局
- Development of a quantitative Polymerase Chain Reaction (qPCR) test for clinical use(1 year)