A Prospective Clinical Study to Validate a Preoperative Risk Scoring Model for Lymph Node Metastasis in Gastric Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- lymph node metastasis
研究概览
简要总结
In our prior research, a risk scoring model for the occurrence of lymph node metastasis in patients who underwent radical gastrectomy for gastric cancer was established. To further validate this scoring model, a prospective study has been designed with the aim of prospectively assessing the model's clinical applicability.
详细描述
The study was a single-centre, prospective study. Data prospectively accrued were employed to evaluate the concordance between observed patient outcomes, with respect to lymph node metastasis status post-curative gastrectomy, and the prognostications tendered by the established risk scoring model, thereby appraising the model's clinical applicability and validity.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary gastric adenocarcinoma;
- •Curative surgery (with R0 resection, excluding palliative surgery and cases with distant metastasis).
排除标准
- •Patients with autoimmune diseases, inflammation, or hematological disorders;
- •Patients with a history of or concurrent other cancers;
- •Presence of active infection and inflammation (based on WBC count, patients with count of 10×10^9 or higher should be evaluated through medical record examination for the presence of infection);
- •Active bleeding (as determined by endoscopic ultrasound and HGB ≤ 90);
- •Post neoadjuvant radiotherapy or chemotherapy;
- •History of blood transfusion, corticosteroid use, or leukocyte-stimulating medications within the past month prior to blood draw;
- •Incomplete clinical and pathological data.
结局指标
主要结局
lymph node metastasis
时间窗: 1 month after curative surgery
Collect postoperative pathological data from gastric cancer patients who have undergone curative gastrectomy to determine the occurrence of lymph node metastasis.
次要结局
未报告次要终点