Spanish Registry of Esophagogastric Cancer (AGAMENON)

AGAMENON-SEOM Study: Spanish Registry of Esophagogastric Cancer

This study aims to development of a database through a web page for epidemiological and clinical research purposes that is accessible to members of the AGAMENON - SEOM group that guarantees a rigorous collection, exploitation and analysis of the data and information contained, increases the knowledge of esophageal and stomach cancer in order to optimize the management, treatment and evolution of patients, the possibility of comparing variables with those of other series or groups, and promotes the quality of scientific publications.

Study Overview

Detailed Description

Patient data will be collected from medical records retrospectively.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Alicante, Spain, 03010
        • Recruiting
        • Hospital General Universitario de Alicante
        • Contact:
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
        • Contact:
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
        • Contact:
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
      • Ciudad Real, Spain, 13005
        • Recruiting
        • Hospital General Universitario de Ciudad Real
        • Contact:
      • Jaén, Spain, 23007
        • Recruiting
        • Hospital Universitario de Jaén
        • Contact:
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
      • Madrid, Spain, 28047
        • Recruiting
        • Hospital Central de la Defensa Gomez Ulla
        • Contact:
      • Ourense, Spain, 32005
        • Recruiting
        • Complejo Hospitalario Universitario de Ourense
        • Contact:
      • Pamplona, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra
        • Contact:
      • Pontevedra, Spain, 36002
        • Recruiting
        • Hospital Provincial de Pontevedra
        • Contact:
      • Salamanca, Spain, 37007
        • Recruiting
        • Complejo Asistencial Universitario de Salamanca
        • Contact:
      • Santa Cruz De Tenerife, Spain, 38010
        • Recruiting
        • Hospital Universitario Nuestra Señora de la Candelaria
        • Contact:
      • Valencia, Spain, 46014
        • Recruiting
        • Hospital General Universitario de Valencia
        • Contact:
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Recruiting
        • Hospital General Universitario de Elche
        • Contact:
      • Elda, Alicante, Spain, 03600
        • Recruiting
        • Hospital General Universitario de Elda
        • Contact:
    • Andalucia
      • Sevilla, Andalucia, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
    • Andalucía
      • Córdoba, Andalucía, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
      • Málaga, Andalucía, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga
        • Contact:
      • Sevilla, Andalucía, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Institut Catala d'Oncologia
        • Contact:
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Universitari Parc Tauli
        • Contact:
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecillas
        • Contact:
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Spain, 07120
        • Recruiting
        • Hospital Universitario Son Espases
        • Contact:
      • Palma De Mallorca, Islas Baleares, Spain, 07198
        • Recruiting
        • Hospital Son Llatzer
        • Contact:
    • La Coruña
      • A Coruña, La Coruña, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario de A Coruña
        • Contact:
    • La Rioja
      • Logroño, La Rioja, Spain, 26006
        • Recruiting
        • Hospital San Pedro
        • Contact:
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Recruiting
        • Hospital Universitario Fundación Alcorcón
        • Contact:
    • Murcia
      • Cartagena, Murcia, Spain, 30202
        • Recruiting
        • Hospital General Universitario Santa Lucía
        • Contact:
    • Región de Murcia
      • Murcia, Región de Murcia, Spain, 30008
        • Recruiting
        • Hospital General Universitario Morales Meseguer
        • Contact:
    • Santa Cruz de Tenerife
      • San Cristóbal de la Laguna, Santa Cruz de Tenerife, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias
        • Contact:
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Recruiting
        • Hospital Universitario de Galdakao
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study plans to enroll patients with histologically confirmed carcinoma of the esophagus, gastroesophageal junction, and stomach. The inclusion of patients is required to be done consecutively, being valid any time point if data are available.

Description

Inclusion Criteria:

  • Adult patient (≥18 years) diagnosed with carcinoma of the esophagus, gastroesophageal junction and stomach, including all histologic subtypes, with or without erbB2 overexpression (and tumors in which this data is unknown).
  • Follow-up of at least 3 months with clinical information during this period, exempting patients with early death from any cause.

Exclusion Criteria:

  • A patient for whom, for whatever reason, the information necessary to complete the database cannot be known or obtained.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Resectable non-advanced cancer
Surgery
Chemotherapy, anti-targeted agents and immunotherapy
Radiotherapy
Cohort 2
Unresectable advanced cancer
Surgery
Chemotherapy, anti-targeted agents and immunotherapy
Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic and therapeutic approach
Time Frame: Up to 12 months
To evaluate survival (time in months) according to treatment of esophagogastric cancer in all stages, patients, and contexts.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiological profiles
Time Frame: Up to 12 months
To know the epidemiological profiles of esophagogastric cancer in Spain: temporal and regional trends, morbidity, and mortality.
Up to 12 months
Risk factors
Time Frame: Up to 12 months
To study risk factors associated with each subtype of esophagogastric cancer and localization.
Up to 12 months
Pathological features
Time Frame: Up to 12 months

To evaluate the pathological features (TNM, grade, histological response)

The TNM is measured with the American Joint Committee on Cancer (AJCC) staging system.

The grade is classified with the WHO scale. Histological response is measured with Becker classification.

Up to 12 months
Clinical and diagnostic approach
Time Frame: Up to 12 months

To know the diagnostic approch according to the center, type of studies performed: endoscopy, CT, echoendoscopy and/or PET/CT.

From these studies it will be collected whether they have been carried out and where they visualise tumour. The use of scales and measurements is therefore not appropriate.

Up to 12 months
Treatments adjusted to prognostic variables
Time Frame: Up to 12 months
To compare treatments adjusted to prognostic variables and baseline characteristics.
Up to 12 months
Validate and compare prognostic models
Time Frame: Up to 12 months
To validate and compare the three prognostic models for advanced esophagogastric adenocarcinoma: The Royal Marsden Hospital index (Chau et al, 2004), and the models of Kim (2008) and Lee (2007), in a real sample of patients based on daily clinical practice.
Up to 12 months
Prognostic factors
Time Frame: Up to 12 months
To analyze the prognostic factors in this population and build a predictive and/or prognostic model.
Up to 12 months
Create and validate a predictive model
Time Frame: Up to 12 months
To create and validate a predictive model of early mortality.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Paula Dr Jiménez Fonseca, MD-PhD, Sociedad Española de Oncología Médica (SEOM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2020

Primary Completion (Estimated)

December 1, 2034

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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