Spots Global Cancer Trial Database for A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis
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Trial Identification
Brief Title: A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis
Official Title: A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis: A Prospective, Multicenter, Cohort Study
Study ID: NCT04440605
Study Description
Brief Summary: 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.
Detailed Description: 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. Patients are divided into 3 preoperative stage groups according to AJCC 8th edition (cI, cII, cIII) preoperatively. All patients receive the D2 gastrectomy after cTNM diagnosis and the pathological stages is given following surgery. The concordance of preoperative staging is evaluated in each cohorts as well as the subgroups to obtain the accuracy rate. The pI proportion will calculate in each latent criterion groups to assess the suitable NAC criteria. PROJECTED ACCRUAL: A total of 968 patients will be accrued for this study within two years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking University Cancer Hospital & Institute, Beijing, Beijing, China
301 Hospital, Beijing, Beijing, China
302 Military Hospital of China, Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, China
Beijing Hospital, Beijing, Beijing, China
Peking University International Hospital, Beijing, Beijing, China
Peking University Peoples Hospital, Beijing, Beijing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Fujian Tumor Hospital, Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
Zhongshan Hospital of Xiamen University, Xiamen, Fujian, China
Guangdong General Hospital, Guangzhou, Guangdong, China
Guangdong Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Heilongjiang Cancer Hospital, Harbin, Heilongjiang, China
Wuhan Union Hospital, Wuhan, Hubei, China
Jiangsu People's Hospital, Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
The First Hospital of Jilin University, Chang chun, Jilin, China
The Second Hospital of Jilin University, Chang chun, Jilin, China
The Second Affiliated Hospital-Dalian Medical University, Dalian, Liaoning, China
Qinghai University Affiliated Hospital, Xining, Qinghai, China
First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
Shandong Provincial Hospital, Jinan, Shandong, China
Qingdao Municipal Hospital, Qingdao, Shandong, China
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
Weifang People's Hospital, Weifang, Shandong, China
Fudan University Cancer center, Shanghai, Shanghai, China
Ruijin Hospital, Shanghai, Shanghai, China
Shanghai Renji Hospital, Shanghai, Shanghai, China
Zhongshan Hospital, Shanghai, Shanghai, China
Shanxi Tumour Hospital, Taiyuan, Shanxi, China
West China Hospital, Chendu, Sichuan, China
Tianjin Medical University Cancer Hospital, Tianjin, Tianjin, China
Tianjin Medical University General Hospital, Tianjin, Tianjin, China
First Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, China
Contact Details
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