NCT07781319

Brief Summary

Early gastric cancer (EGC) is increasingly diagnosed in Western countries; however, important differences remain with Eastern populations regarding staging accuracy, treatment strategies, and the risk of lymph node metastasis. While endoscopic resection is the standard treatment for selected EGC in Asia based on well-established criteria, the applicability of these criteria to Western populations remains uncertain because of differences in epidemiology, clinical practice, and pathological characteristics. This multicenter retrospective cohort study, based on the Spanish EURECCA Registry, aims to evaluate the concordance between clinical and pathological staging, determine the real incidence and predictors of lymph node metastasis in patients with pathological T1 gastric cancer, assess the applicability of standard and expanded Asian endoscopic resection criteria in a Western cohort, and analyze long-term oncological outcomes, including recurrence and overall survival.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

8.9 years

First QC Date

August 16, 2026

Last Update Submit

August 19, 2026

Conditions

Keywords

Early Gastric CancerGastric AdenocarcinomaClinical StagingPathological StagingLymph Node MetastasisWestern PopulationMulticenter Registry

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Concordant Clinical and Pathological Staging

    Percentage of participants in whom preoperative clinical staging (cT and cN) was concordant with final pathological staging (pT and pN). Concordance will be assessed by comparing clinical and pathological tumor depth and lymph node status.

    Baseline

  • Lymph node metastasis

    Percentage of participants with pathological lymph node metastasis (pN+) among patients with pathological T1 gastric adenocarcinoma. Lymph node status will be determined from the definitive pathological examination of the surgical specimen.

    Baseline

Secondary Outcomes (7)

  • Applicability of Standard Asian Endoscopic Resection Criteria

    Baseline

  • Applicability of Expanded Asian Endoscopic Resection Criteria

    Baseline

  • Overall Survival

    Up to 5 years after surgery

  • Disease-Free Survival

    Up to 5 years after surgery

  • Percentage of Participants With Tumor Recurrence

    Up to 5 years after surgery

  • +2 more secondary outcomes

Study Arms (1)

Early Gastric Cancer Cohort

Patients with surgically treated early gastric adenocarcinoma (pathological T1) included in the multicenter Spanish EURECCA Registry between January 2014 and December 2022. Patients underwent curative-intent gastrectomy with lymph node dissection according to routine clinical practice at participating centers. Clinical, pathological, treatment, and follow-up data were retrospectively analyzed.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients with a preoperative clinical diagnosis of early gastric cancer (cT1) who underwent curative-intent gastrectomy with lymph node dissection at participating centers of the Spanish EURECCA Registry between January 2014 and December 2022. The cohort includes patients with histologically confirmed gastric adenocarcinoma and complete clinicopathological and follow-up data available for analysis. This population was selected to evaluate the accuracy of preoperative clinical staging and to investigate the pathological characteristics and oncological outcomes of early gastric cancer in a Western multicenter cohort.

You may qualify if:

  • Adults (≥18 years of age)
  • Clinical diagnosis of early gastric cancer (cT1) before surgery.
  • Curative-intent gastrectomy with lymph node dissection performed between
  • January 2014 and December 2022.
  • Histologically confirmed gastric adenocarcinoma.
  • Availability of complete preoperative clinical staging, pathological findings, and follow-up data required for the study analyses.

You may not qualify if:

  • Receipt of neoadjuvant therapy before surgery.
  • Incomplete pathological data precluding accurate tumor staging or lymph node assessment.
  • Non-adenocarcinoma gastric tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 16, 2026

First Posted

August 24, 2026

Study Start

January 1, 2014

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

August 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share