Molecular Assessment for Gastro-Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Identification of the concentrations of oncometabolites
研究概览
简要总结
The goal of this minimally invasive interventional study is to learn if oncometabolic biomarkers, detected in the exhaled breath and blood can identify early-stage gastro-oesophageal cancer in patient at risk for gastro-oesophageal cancer.
The main questions this study aims to answer:
Are oncometabolites proficient and reproducible enough to function as diagnostic biomarkers? Can these biomarkers identify early-stage gastro-esophageal cancer? Researchers will compare participants with gastro-oesophageal cancer to healthy controls and participants with Barrett's esophagus to detect meaningful differences between the groups.
Participants will provide a breath and blood sample during their routine standard of care visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any breath or blood analysis
- •>18 years old
- •Barrett's esophagus or treatment naïve gastro-esophageal cancer stage I to IV
- •Voluntary healthy controls
排除标准
- •<18 years old
- •Patient has history of:
- •Active other cancer than gastro-esophageal cancer
- •Prior cancer treated <3 years ago
- •Hepatic dysfunction/liver failure (MELT >7)
- •Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the study plan.
- •Insufficient/unreliable quality of breath (e.g., breath flow) or plasma sample (e.g., haemolytic sample)
- •Incarcerated individuals
研究组 & 干预措施
Gastro-esophageal cancer group
Participants with gastroesophageal cancer providing a breath and blood sample for biomarker identification
干预措施: Breath analysis (Diagnostic Test)
Gastro-esophageal cancer group
Participants with gastroesophageal cancer providing a breath and blood sample for biomarker identification
干预措施: Blood analysis (Diagnostic Test)
Barrett's esophagus group
Participants with Barrett's esophagus providing a breath and blood sample for biomarker identification
干预措施: Breath analysis (Diagnostic Test)
Barrett's esophagus group
Participants with Barrett's esophagus providing a breath and blood sample for biomarker identification
干预措施: Blood analysis (Diagnostic Test)
Healthy controls
Healthy controls providing a breath and blood sample for biomarker identification
干预措施: Breath analysis (Diagnostic Test)
Healthy controls
Healthy controls providing a breath and blood sample for biomarker identification
干预措施: Blood analysis (Diagnostic Test)
结局指标
主要结局
Identification of the concentrations of oncometabolites
时间窗: year 1-2
Identify the concentrations of cancer-related metabolites (oncometabolites) in the exhaled breath and blood compared to healthy controls
次要结局
- Assessment of incidence of recurrence(year 2-5)
- Assessment of incidence of early-stage cancer(year 2-5)
- Assessment of incidence of therapy response(year 2-5)
- Assessment of percentage change of therapy response(year 2-5)
研究者
Stijn Vanstraelen
Principal investigator
Universitaire Ziekenhuizen KU Leuven