Early Gastric CancerNCT07781319
Early Gastric Cancer in the Spanish EURECCA Registry
An observational study of Early Gastric Cancer and Gastric Adenocarcinoma, run by Corporacion Parc Tauli.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Gastric Cancer, Gastric Adenocarcinoma
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Receipt of neoadjuvant therapy before surgery.
- Incomplete pathological data precluding accurate tumor staging or lymph node assessment.
- Non-adenocarcinoma gastric tumors.
About this study
Official title: Differences Between Clinical and Pathological Staging in Early Gastric Cancer (EGC): Evaluation of the Potential Impact of Applying Standard and Expanded Asian Endoscopic Resection Criteria in a Western Cohort and Analysis of Disease Progression and Long-Term Survival
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.
Read the detailed description
Early gastric cancer (EGC) is defined as gastric adenocarcinoma confined to the mucosa or submucosa regardless of lymph node status. Although endoscopic resection has become the standard treatment for selected patients in Eastern countries, its use in Western populations remains controversial because most recommendations are based on Asian cohorts with different epidemiological characteristics, screening strategies, and clinical practice.
Accurate preoperative staging is essential for selecting the optimal therapeutic approach. However, the concordance between clinical staging and final pathological findings remains suboptimal, particularly regarding depth of invasion and lymph node involvement. These limitations may result in both overtreatment and undertreatment of patients with EGC.
The Spanish EURECCA Registry provides a large multicenter cohort of surgically treated patients with standardized clinicopathological data collected from routine clinical practice. This study will evaluate the agreement between clinical and pathological staging, characterize the risk factors associated with lymph node metastasis, retrospectively assess the applicability of standard and expanded Asian endoscopic resection criteria in a Western population, and investigate long-term oncological outcomes. The results are expected to provide evidence supporting treatment decision-making and the potential implementation of less invasive therapeutic strategies in appropriately selected Western patients.
- Conditions
- Early Gastric Cancer, Gastric Adenocarcinoma
- Keywords
- Early Gastric Cancer, Gastric Adenocarcinoma, Clinical Staging, Pathological Staging, Lymph Node Metastasis, Western Population, Multicenter Registry
- Medical subject headings
- Stomach Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (7)
Applicability of Standard Asian Endoscopic Resection Criteria
Assessment of the proportion of patients fulfilling the standard Asian endoscopic resection criteria and evaluation of the associated risk of lymph node metastasis.
Measured: Baseline
Applicability of Expanded Asian Endoscopic Resection Criteria
Assessment of the proportion of patients fulfilling the expanded Asian endoscopic resection criteria and evaluation of the associated risk of lymph node metastasis.
Measured: Baseline
Overall Survival
Overall survival measured from the date of surgery to death from any cause or last follow-up.
Measured: Up to 5 years after surgery
Disease-Free Survival
Disease-free survival measured from the date of surgery to disease recurrence, death, or last follow-up.
Measured: Up to 5 years after surgery
Percentage of Participants With Tumor Recurrence
Percentage of participants who develop local, regional, or distant tumor recurrence after curative-intent surgery.
Measured: Up to 5 years after surgery
Percentage of Participants Correctly Classified by Preoperative Clinical Staging
Percentage of participants in whom preoperative clinical staging correctly predicts the final pathological tumor stage (pT) and lymph node status (pN). Diagnostic performance will also be assessed using sensitivity, specificity, positive predictive value, and negative predictive value, as applicable.
Measured: Baseline
Percentage of Participants Correctly Classified by Endoscopic Ultrasonography
Percentage of participants in whom preoperative endoscopic ultrasonography correctly predicts the final pathological tumor invasion depth (pT stage) and lymph node status (pN). Diagnostic performance will also be assessed using sensitivity, specificity, positive predictive value, and negative predictive value, as applicable.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startJan 2014
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish EURECCA Group for Esophagogastric Surgery (GEECEG)
- Responsible party
- Principal investigator, Noelia Pérez Romero, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781319
- Sponsor's protocol ID
- PT-EGC-2026-089
- Other IDs
- CEIm 2026.089-50
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences Between Clinical and Pathological Staging in Early Gastric Cancer (EGC): Evaluation of the Potential Impact of Applying Standard and Expanded Asian Endoscopic Resection Criteria in a Western Cohort and Analysis of Disease Progression and Long-Term Survival
- ClinicalTrials.gov ID
- NCT07781319
- Acronym / sponsor ID
- PT-EGC-2026-089
- Conditions
- Early Gastric Cancer, Gastric Adenocarcinoma
- Keywords
- Early Gastric Cancer, Gastric Adenocarcinoma, Clinical Staging, Pathological Staging, Lymph Node Metastasis, Western Population, Multicenter Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Spanish EURECCA Group for Esophagogastric Surgery (GEECEG)
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Early gastric cancer (EGC) is defined as gastric adenocarcinoma confined to the mucosa or submucosa regardless of lymph node status. Although endoscopic resection has become the standard treatment for selected patients in Eastern countries, its use in Western populations remains controversial because most recommendations are based on Asian cohorts with different epidemiological characteristics, screening strategies, and clinical practice.
Accurate preoperative staging is essential for selecting the optimal therapeutic approach. However, the concordance between clinical staging and final pathological findings remains suboptimal, particularly regarding depth of invasion and lymph node involvement. These limitations may result in both overtreatment and undertreatment of patients with EGC.
The Spanish EURECCA Registry provides a large multicenter cohort of surgically treated patients with standardized clinicopathological data collected from routine clinical practice. This study will evaluate the agreement between clinical and pathological staging, characterize the risk factors associated with lymph node metastasis, retrospectively assess the applicability of standard and expanded Asian endoscopic resection criteria in a Western population, and investigate long-term oncological outcomes. The results are expected to provide evidence supporting treatment decision-making and the potential implementation of less invasive therapeutic strategies in appropriately selected Western patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Receipt of neoadjuvant therapy before surgery.
- Incomplete pathological data precluding accurate tumor staging or lymph node assessment.
- Non-adenocarcinoma gastric tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With Concordant Clinical and Pathological Staging
Time frame: Baseline
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.
Lymph node metastasis
Time frame: Baseline
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.
7 secondary outcomes
Applicability of Standard Asian Endoscopic Resection Criteria
Time frame: Baseline
Applicability of Expanded Asian Endoscopic Resection Criteria
Time frame: Baseline
Overall Survival
Time frame: Up to 5 years after surgery
Disease-Free Survival
Time frame: Up to 5 years after surgery
Percentage of Participants With Tumor Recurrence
Time frame: Up to 5 years after surgery
Percentage of Participants Correctly Classified by Preoperative Clinical Staging
Time frame: Baseline
Percentage of Participants Correctly Classified by Endoscopic Ultrasonography
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Gastric Cancer and Gastric Adenocarcinoma, run by Corporacion Parc Tauli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Concordant Clinical and Pathological Staging (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.