Early Detection of Stomach Cancer With a Liquid Biopsy Based on Exosomal Micro-RNA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 809
- 试验地点
- 3
- 主要终点
- Sensitivity
研究概览
简要总结
Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer.
详细描述
Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. Because conventional endoscopy is invasive and costly, gastric cancer is currently not considered to be screenable at a population level. However, if one could find less invasive and cheaper tools that accurately detect gastric cancer in its early stages, it could make a significant difference. Accurate biomarkers could help identify patients with gastric cancer before it becomes incurable.
This study aims to develop a non-invasive test to detect gastric cancer early. It consists of four phases:
- Discovering potential biomarkers with a comprehensive and genome-wide transcriptomic sequencing analysis that will involve gastric cancer tissue, normal tissue, and serum samples from patients with gastric cancer, as well as samples from people without the disease.
- Using machine learning to develop a combination "signature" of cell-free (cf) and exosomal (exo)-miRNA in serum specimens from a training cohort.
- A validation of this signature in an independent cohort to confirm its accuracy.
- An evaluation of the temporal trend of this signature in paired samples collected pre-surgery and post-surgery to investigate their potential and specificity as indicators of minimal residual disease.
In summary, this study aims to develop a highly accurate and cost-effective blood test for detecting gastric cancer early. Success could lead to significant improvements in clinical practice by catching cancer when it is most treatable. By combining different genetic markers (cell-free microRNA and exosomal microRNA) for accuracy, this study has the potential to reduce gastric cancer deaths and could lead to new screening methods in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Histological diagnosis of stage I, II, III, IV gastric cancer (TNM classification, 8th edition) (cases).
- •Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.
- •Confirmed cancer-free status at the time of study inclusion (Non-disease controls).
排除标准
- •Lack of written informed consent.
- •Systemic therapy before sampling.
- •Synchronous gastric and non-gastric cancer diagnosed at or before surgery.
结局指标
主要结局
Sensitivity
时间窗: Through study completion, an average of 1 year
True positive rate: the probability of a positive test result, conditioned on the individual truly being positive
次要结局
- Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy)(Through study completion, an average of 1 year)
- Specificity(Through study completion, an average of 1 year)