A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis

NCT04440605 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 968

Last updated 2020-06-19

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Preoperative staging--D2 gastrectomy--Postoperative staging

Preoperative TNM staging under CT scan plus endoscopy endoscopic biopsy, and postoperative staging after D2 gastrectomy

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER
  • Ruijin Hospital

    collaborator OTHER
  • West China Hospital

    collaborator OTHER
  • Beijing 302 Hospital

    collaborator OTHER
  • Fudan University

    collaborator OTHER
  • Peking University International Hospital

    collaborator OTHER
  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    collaborator OTHER
  • Fujian Medical University Union Hospital

    collaborator OTHER
  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER
  • Chinese PLA General Hospital

    collaborator OTHER
  • First Affiliated Hospital of Xinjiang Medical University

    collaborator OTHER
  • Tianjin Medical University General Hospital

    collaborator OTHER
  • The Second Affiliated Hospital of Dalian Medical University

    collaborator OTHER
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER
  • Peking University People's Hospital

    collaborator OTHER
  • Weifang People's Hospital

    collaborator OTHER
  • Second Hospital of Jilin University

    collaborator OTHER
  • Fujian Province Tumor Hospital

    collaborator OTHER
  • Shanxi Province Cancer Hospital

    collaborator OTHER
  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER
  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER
  • Shanghai Zhongshan Hospital

    collaborator OTHER
  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER
  • The Affiliated Hospital of Qingdao University

    collaborator OTHER
  • The First Affiliated Hospital of Xiamen University

    collaborator OTHER
  • Beijing Hospital

    collaborator OTHER_GOV
  • Beijing Friendship Hospital

    collaborator OTHER
  • Qingdao Municipal Hospital

    collaborator OTHER
  • Guangdong Provincial People's Hospital

    collaborator OTHER
  • Affiliated Hospital of Qinghai University

    collaborator OTHER
  • Shandong Provincial Hospital

    collaborator OTHER_GOV
  • The First Hospital of Jilin University

    collaborator OTHER
  • Nanfang Hospital, Southern Medical University

    collaborator OTHER
  • Zhongshan Hospital Xiamen University

    collaborator OTHER
  • Hebei Medical University Fourth Hospital

    collaborator OTHER
  • Peking University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-04-30
Completion
2022-10-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04440605 on ClinicalTrials.gov