Multicenter Study of Clinical-Pathological Correlation in cT2N0 Gastric Cancer and Its Prognostic Implications

NCT07842549 | Completed

• 1 other identifier: HUN
• Study Type: observational
• Target: 1,024
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastric Cancer (Diagnosis); TNM Staging; Gastric Surgery; Perioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Cancer

Keywords

Gastric cancer; T2N0

Outcome Measures

Primary Outcomes (1)

• Concordance between preoperative clinical staging and final pathological staging,

  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.

  through study completion, an average of 5 year

Secondary Outcomes (9)

• Understaging adn overstaging rates

  through study completion, an average of 5 year

• Accuracy of T and N

  through study completion, an average of 5 year

• Understaging variables

  through study completion, an average of 5 years

• Echoendoscopy role

  through study completion, an average of 5 years

• Impact on survival

  through study completion, an average of 5 years

Study Arms (1)

Patients with T2N0 gastric cancer

Gastric adenocarcinoma, cT2M0, surgery with or without neoadyuvant treatment, pTNM

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Clinical factors: age, sex, ASA status, Charlson score, frailty (Veljanovich Modified Frailty Index), tumor markers (CEA, CA 19.9). Preoperative diagnosis: CT scan, endoscopic ultrasound, endoscopic findings, biopsy (Lauren classification, histological grade). Surgical and pathological: type of gastrectomy, lymphadenectomy, pTNM, number of lymph nodes examined, resected, and involved Prognosis: neoadjuvant therapy, ypTNM, recurrence, overall survival, and disease-free survival.

You may qualify if:

• gastric adenocarcinoma, cT2N0 classification (CT scan/echoendoscopy), surgery with or without neoadjuvant therapy, pTNM stage recorded.

You may not qualify if:

• metastatic disease, non-curative resections.

Sponsors & Collaborators

• Hospital of Navarra: lead

Study Sites (1)

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (13)

• Japanese 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 BACKGROUND

• Levenson 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 BACKGROUND

• Su 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 BACKGROUND

• Abboretti 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 BACKGROUND

• Baril 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 BACKGROUND

• Ju 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 BACKGROUND

• Han C, Lin R, Shi H, Liu J, Qian W, Ding Z, Hou X. The role of endoscopic ultrasound on the preoperative T staging of gastric cancer: A retrospective study. Medicine (Baltimore). 2016 Sep;95(36):e4580. doi: 10.1097/MD.0000000000004580.

  PMID: 27603347 BACKGROUND

• da Costa WL, Tran Cao HS, Gu X, Massarweh NN. Understanding the association between clinical staging accuracy, treatment response, and survival among gastric cancer patients through Bayesian analysis. J Surg Oncol. 2022 Nov;126(6):986-994. doi: 10.1002/jso.27016. Epub 2022 Jul 12.

  PMID: 35819061 BACKGROUND

• Janczewski LM, Shah D, Wells A, Bentrem DJ, Abad JD, Chawla A. The inaccuracies of gastric adenocarcinoma clinical staging and its predictive factors. J Surg Oncol. 2023 Jun;127(7):1116-1124. doi: 10.1002/jso.27233. Epub 2023 Mar 11.

  PMID: 36905333 BACKGROUND

• Obermannova RL, Leong T; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. ESMO Clinical Practice Guideline interim update on the treatment of locally advanced oesophageal and oesophagogastric junction adenocarcinoma and metastatic squamous-cell carcinoma. ESMO Open. 2025 Feb;10(2):104134. doi: 10.1016/j.esmoop.2025.104134. Epub 2025 Feb 12.

  PMID: 39986705 BACKGROUND

• Lordick F, Carneiro F, Cascinu S, Fleitas T, Haustermans K, Piessen G, Vogel A, Smyth EC; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022 Oct;33(10):1005-1020. doi: 10.1016/j.annonc.2022.07.004. Epub 2022 Jul 29. No abstract available.

  PMID: 35914639 BACKGROUND

• Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17.

  PMID: 28094848 BACKGROUND

• World Health Organization. Global cancer observatory: Cancer today [Internet]. Lyon: International Agency for Research on Cancer; 2022 [cited 2026 Apr 9].

  BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Disease

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SPECIALIST IN GENERAL SURGERY, PRINCIPAL INVESTIGATOR, MD, PHD

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 25, 2026
• Study Start: January 1, 2014
• Primary Completion: July 8, 2016
• Study Completion: June 1, 2025
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

ES (1)