Detection of Peritoneal Metastasis of Gastric Cancer by Liquid Biopsy in Peripheral Blood: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of the cfDNA methylation-based model in detecting peritoneal metastasis of gastric cancer.
研究概览
简要总结
This study is a prospective, multi-omics, observational study aimed at detecting peritoneal metastasis of gastric cancer by combined assays for methylation of cell-free DNA (cfDNA) and other blood-based biomarkers. The study will enroll 384 participants with gastric cancer.
详细描述
Peritoneal metastasis (PM) in gastric cancer is associated with a poor prognosis.
Laparoscopy with cytology is performed to evaluate for peritoneal spread when considering chemoradiation or surgery. However, the laparoscopy is invasive and the sensitivity of computed tomography (CT) scan is poor for detecting PM. Therefore, it is necessary to evaluate the feasibility of cfDNA methylation and other blood-based biomarkers for the PM diagnosis.
The study will enroll 384 participants with gastric cancer. Baseline blood and diagnosis of PM by laparoscopy with cytology will be collected. Participants with PM will be defined as the case arm and participants without PM will be defined as the control arm. A PM diagnostic model will be developed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for Case Arm Participants:
- •Age 18-74 years at the day of consenting to the study.
- •Able to provide a written informed consent.
- •No prior cancer treatment (local or systematic) with either of the following:
- •A. Pathologically confirmed gastric cancer diagnosis within 42 days prior to blood draw.
- •B. High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw.
- •Diagnosis of peritoneal metastasis by laparoscopy with cytology.
- •Inclusion Criteria for Control Arm Participants:
- •Age 18-74 years at the day of consenting to the study.
- •Able to provide a written informed consent.
- •No prior cancer treatment (local or systematic) with either of the following:
- •A. Pathologically confirmed gastric cancer diagnosis within 42 days prior to blood draw.
- •B. High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw.
- •No peritoneal metastasis detected by laparoscopy with cytology.
排除标准
- •Exclusion Criteria for All Participants:
- •Insufficient qualified blood samples.
- •During pregnancy or lactation.
- •Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
- •Recipient of blood transfusion within 7 days prior to blood draw.
- •Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
- •With other known malignant tumors or multiple primary tumors.
- •Exclusion Criteria for Control Arm Participants:
- •Insufficient qualified blood samples.
- •During pregnancy or lactation.
- •Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
- •Recipient of blood transfusion within 7 days prior to blood draw.
- •Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
- •With other known malignant tumors or multiple primary tumors.
结局指标
主要结局
Sensitivity and specificity of the cfDNA methylation-based model in detecting peritoneal metastasis of gastric cancer.
时间窗: 30 months
Sensitivity and specificity of a cfDNA methylation-based model, in combination with other biomarkers, for detecting peritoneal metastasis of gastric cancer.
时间窗: 30 months
次要结局
未报告次要终点