Clinical trial · Observational
A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis
A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis: A Prospective, Multicenter, Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CT | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer Stage | Gastric Neoplasm | PROBABILISTIC | 0.70 |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative staging--D2 gastrectomy--Postoperative staging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- cI
- description
- clincal TNM stage I
- interventionNames
- Procedure: Preoperative staging--D2 gastrectomy--Postoperative staging
- label
- cII
- description
- clinical TNM stage II
- interventionNames
- Procedure: Preoperative staging--D2 gastrectomy--Postoperative staging
- label
- cIII
- description
- clinical TNM stage III
- interventionNames
- Procedure: Preoperative staging--D2 gastrectomy--Postoperative staging
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Discovery of distant metastasis (stage IV) during surgery * Number of retrieved lymph node less than 15
References
Publications (1)
- BACKGROUNDFukagawa T, Katai H, Mizusawa J, Nakamura K, Sano T, Terashima M, Ito S, Yoshikawa T, Fukushima N, Kawachi Y, Kinoshita T, Kimura Y, Yabusaki H, Nishida Y, Iwasaki Y, Lee SW, Yasuda T, Sasako M; Stomach Cancer Study Group of the Japan Clinical Oncology Group. A prospective multi-institutional validity study to evaluate the accuracy of clinical diagnosis of pathological stage III gastric cancer (JCOG1302A). Gastric Cancer. 2018 Jan;21(1):68-73. doi: 10.1007/s10120-017-0701-1. Epub 2017 Feb 13. PMID 28194522