Clinical trial · Observational
Multicenter Study of Clinical-Pathological Correlation in cT2N0 Gastric Cancer and Its Prognostic Implications
MULTICENTER STUDY OF CLINICAL-PATHOLOGICAL CORRELATION IN cT2N0 GASTRIC CANCER AND ITS PROGNOSTIC IMPLICATIONS
NCT07842549CI-TRIAL-00126608completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Gastric Cancer (Diagnosis) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Surgery | — | UNRESOLVED | — |
| Perioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Cancer | Gastric Neoplasm | PROBABILISTIC | 0.70 |
| TNM Staging | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients with T2N0 gastric cancer
- description
- Gastric adenocarcinoma, cT2M0, surgery with or without neoadyuvant treatment, pTNM
Primary outcomes (1)
- measure
- Concordance between preoperative clinical staging and final pathological staging,
- timeFrame
- through study completion, an average of 5 year
- description
- 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.
Secondary outcomes (9)
- measure
- Understaging adn overstaging rates
- timeFrame
- through study completion, an average of 5 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * gastric adenocarcinoma, cT2N0 classification (CT scan/echoendoscopy), surgery with or without neoadjuvant therapy, pTNM stage recorded. Exclusion Criteria: * metastatic disease, non-curative resections.
References
Publications (13)
- BACKGROUNDJapanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available. PMID 32060757
- BACKGROUNDLevenson G, Voron T, Paye F, Balladur P, Debove C, Chafai N, De Dios AG, Lefevre JH, Parc Y. Tumor downstaging after neoadjuvant chemotherapy determines survival after surgery for gastric adenocarcinoma. Surgery. 2021 Dec;170(6):1711-1717. doi: 10.1016/j.surg.2021.08.021. Epub 2021 Sep 22. PMID 34561115
- BACKGROUNDSu P, Zhang Y, Yu T, Jiang L, Kang W, Liu Y, Yu J. Does postoperative chemotherapy improve overall survival of patients with ypT1-2N0 cancer? World J Surg Oncol. 2022 Dec 27;20(1):408. doi: 10.1186/s12957-022-02881-y. PMID 36572874
- BACKGROUNDAbboretti F, Lambert C, Schafer M, Pereira B, Le Roy B, Mege D, Piessen G, Gagniere J, Gronnier C, Mantziari S; ADENOKGAST Study Group; AFC-French Association of Surgery. Neoadjuvant Chemotherapy Does Not Improve Survival in cT2N0M0 Gastric Adenocarcinoma Patients: A Multicenter Propensity Score Analysis. Ann Surg Oncol. 2024 Aug;31(8):5273-5282. doi: 10.1245/s10434-024-15418-2. Epub 2024 May 18. PMID 38762640
- BACKGROUNDBaril JA, Ruedinger BM, Nguyen TK, Bilimoria KY, Ceppa EP, Maatman TK, Roch AM, Schmidt CM, Turk A, Yang AD, House MG, Ellis RJ. Staging accuracy in patients with clinical T2N0 gastric cancer: Implications for treatment sequencing. Surgery. 2025 Mar;179:108796. doi: 10.1016/j.surg.2024.07.055. Epub 2024 Oct 2. PMID 39358121
- BACKGROUNDJu MR, Karalis JD, Blackwell JM, Mansour JC, Polanco PM, Augustine M, Yopp AC, Zeh HJ 3rd, Wang SC, Porembka MR. Inaccurate Clinical Stage Is Common for Gastric Adenocarcinoma and Is Associated with Undertreatment and Worse Outcomes. Ann Surg Oncol. 2021 May;28(5):2831-2843. doi: 10.1245/s10434-020-09403-8. Epub 2021 Jan 2. PMID 33389294