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临床试验/NCT04440605
NCT04440605Unknown不适用

A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis: A Prospective, Multicenter, Cohort Study

Peking University38 个研究点 分布在 1 个国家目标入组 968 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
968
试验地点
38
主要终点
Diagnostic Accuracy of cIII

研究概览

简要总结

With the introducing of neoadjuvant therapy, it becomes ever more important to evaluate the preoperative TNM (cTNM) stage accurately facilitating preoperative treatment as well as the adjuvant therapy.

At present, the recommendation of neoadjuvant chemotherapy varies among guidelines especially between eastern and western countries. According to the updated Japanese gastric cancer treatment guidelines (ver.5), neoadjuvant chemotherapy is the recommended standard procedure for patients with cT2-4 stages. However, the acknowledgement of preoperative therapy accompanied by the higher risk of overtreatment. As mentioned in JCOG1302-A, the overall precision rate in cT staging is 38.8%. Patients diagnosed with pI stages postoperatively account for 6.5% in cT3-4N+ treatment indicating more likely to avoiding the overtreatment comparing to patients with other cT stages.

Inspired by JCOG1302-A, this multicentre study prospectively collect data in preoperative TNM staging assessment using CT(computed tomography, CT) scan and the postoperative TNM (pTNM) staging according to histopathologically examination. By analyzing the accordance between the cTNM and pTNM, this study aims to evaluate the current accuracy of the cTNM staging in china, verifying the proportion of pI stages less than 5% in cIII stage diagnosis patients, learning the overtreating rate in neoadjuvant chemotherapy in China and furthermore, to discover the scope of beneficiaries for neoadjuvant chemotherapy.

详细描述

OBJECTIVES:

I. Confirm the inclusion of pathological stage I (pI) among clinical stage III(T3-4aNx) (cIII) diagnosis patients less than 5% II. Figure out the suitable criterion of NAC and avoid overtreatment, by examining the rate of pI rate in different diagnostic criterion groups, including cIII, TxNy(x+y>4), cN1-3, cT3-4.

III. Evaluate the current state of diagnostic accuracy of preoperative CT staging in china.

OUTLINE:

This is a prospective, multi-centers, cohort study of clinical TNM staging diagnostic accuracy.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histological prove of adenocarcinoma of the stomach by endoscopy
  • Preoperative imaging data by contrast-enhanced CT and clinical TNM stages were given
  • No evidence of stage IV disease
  • No previous gastrectomy or preoperative treatment.

排除标准

  • Discovery of distant metastasis (stage IV) during surgery
  • Number of retrieved lymph node less than 15

结局指标

主要结局

Diagnostic Accuracy of cIII

时间窗: 1.5 years

Proportion of pathological stage I among clinical stage III(T3-4aNx) diagnosis patients

次要结局

  • Diagnostic Accuracy of cTxNy(1.5 years)
  • Diagnostic Accuracy of cTN(1.5 years)
  • Diagnostic Accuracy of cN+(1.5 years)
  • Diagnostic Accuracy of cT3/4(1.5 years)

研究者

发起方
Peking University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ziyu Li, MD

M.D., Ph.D.

Peking University

研究点 (38)

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