MULTICENTER STUDY OF CLINICAL-PATHOLOGICAL CORRELATION IN cT2N0 GASTRIC CANCER AND ITS PROGNOSTIC IMPLICATIONS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,024
- 试验地点
- 1
- 主要终点
- Concordance between preoperative clinical staging and final pathological staging,
研究概览
简要总结
In gastric cancer, accurate preoperative staging of patients with T2N0 disease remains challenging. Correct assessment of tumor depth and lymph node involvement is particularly important in this subgroup, as treatment strategies may differ depending on the final stage. This study aims to correlate preoperative diagnostic findings with postoperative histopathological results in patients with suspected T2N0 gastric cancer, in order to assess the accuracy of current staging modalities and identify factors that may improve preoperative staging and guide treatment selection.
详细描述
Gastric cancer remains one of the leading causes of cancer-related mortality worldwide, ranking fifth in incidence and fourth as a cause of cancer-related death, according to the latest data from the World Health Organization (WHO). Currently, treatment selection for resectable disease is based on the clinical TNM classification according to the 8th edition of the American Joint Committee on Cancer (AJCC), which allows for differentiation between early-stage tumors eligible for resection as the first (primary) treatment and locally advanced disease, in which perioperative treatment has been shown to improve survival.
However, there is a subgroup of patients for whom this approach has significant limitations: those diagnosed with cT2N0 gastric cancer.
The cT2N0 stage represents a transition point between early-stage and locally advanced disease, where the indication for primary surgery or perioperative treatment is controversial. Population-based studies have shown that the concordance between clinical and pathological staging in gastric cancer is suboptimal, with error rates approaching 40%.
This phenomenon is particularly pronounced in the cT2N0 subgroup, where agreement can drop as low as 34.7%, making it the group with the poorest diagnostic accuracy.
In this context, endoscopic ultrasound (EUS) has traditionally been considered the most accurate tool for preoperative locoregional staging of gastric cancer, especially in the assessment of tumor depth (T). EUS allows for detailed visualization of the different layers of the gastric wall, making it the gold standard for assessing tumor invasion. However, current evidence shows more heterogeneous results than previously assumed, with an overall accuracy for T staging of approximately 64.2% .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •gastric adenocarcinoma, cT2N0 classification (CT scan/echoendoscopy), surgery with or without neoadjuvant therapy, pTNM stage recorded.
排除标准
- •metastatic disease, non-curative resections.
研究组 & 干预措施
Patients with T2N0 gastric cancer
Gastric adenocarcinoma, cT2M0, surgery with or without neoadyuvant treatment, pTNM
结局指标
主要结局
Concordance between preoperative clinical staging and final pathological staging,
时间窗: through study completion, an average of 5 year
To evaluate, in a national multicenter cohort of patients with gastric cancer clinically classified as T2N0, the frequency and determinants of discordance between preoperative clinical staging and final pathological staging, with particular emphasis on understaging of the T component and, above all, the N component, as well as its impact on the appropriateness of the initial treatment strategy.
次要结局
- Understaging adn overstaging rates(through study completion, an average of 5 year)
- Accuracy of T and N(through study completion, an average of 5 year)
- Understaging variables(through study completion, an average of 5 years)
- Echoendoscopy role(through study completion, an average of 5 years)
- Impact on survival(through study completion, an average of 5 years)
- Appropriateness of treatment(through study completion, an average of 5 years)
- Impact of under-staging(through study completion, an average of 5 years)
- Relationship between downstaging and oncological outcomes(through study completion, an average of 5 years)
- Predictive model(through study completion, an average of 5 years)
研究者
Ines Eguaras
SPECIALIST IN GENERAL SURGERY, PRINCIPAL INVESTIGATOR, MD, PHD
Hospital of Navarra