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NCT Number: NCT04958720

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Universitario de Alicante, Alicante, Spain

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About this study

Patient data will be collected from medical records retrospectively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery

Procedure

Surgery

Chemotherapy, anti-targeted agents and immunotherapy

Drug

Chemotherapy, anti-targeted agents and immunotherapy

Radiotherapy

Radiation

Radiotherapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Risk factors

    Time frame: Up to 12 months

    To study risk factors associated with each subtype of esophagogastric cancer and localization.

  3. 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.

  4. 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.

  5. Treatments adjusted to prognostic variables

    Time frame: Up to 12 months

    To compare treatments adjusted to prognostic variables and baseline characteristics.

  6. 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.

  7. Prognostic factors

    Time frame: Up to 12 months

    To analyze the prognostic factors in this population and build a predictive and/or prognostic model.

  8. Create and validate a predictive model

    Time frame: Up to 12 months

    To create and validate a predictive model of early mortality.

Study contacts

Contact information is provided by the study sponsor or research team.

Paula Dr Jiménez Fonseca, MD-PhD

CONTACT

[email protected]

985106121 ext. 36582

Sponsors and collaborators

Lead sponsor

Fundación Sociedad Española de Oncologia Médica

Other

Registry information

Official study title

AGAMENON-SEOM Study: Spanish Registry of Esophagogastric Cancer

Acronym: AGAMENON

Important dates

Study start
2020
Primary completion
2034
Study completion
2035
First posted
Jul 12, 2021
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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