Spanish Registry of Esophagogastric Cancer

Gastric Cancer Clinical Trial

— AGAMENON  

Official title:

AGAMENON-SEOM Study: Spanish Registry of Esophagogastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04958720
• Other study ID #: 2020-01
• Secondary ID: RXSCXJ3E6E
• Status: Recruiting
• Start date: April 27, 2020
• Est. completion date: December 1, 2035

Study information

• Verified date: December 2022
• Source: Fundación Sociedad Española de Oncologia Médica
• Contact: Paula Dr Jiménez Fonseca, MD-PhD
• Phone: 985106121
• Email: palucaji[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Patient data will be collected from medical records retrospectively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 1, 2035
• Est. primary completion date: December 1, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Surgery
Surgery

Drug:
• Chemotherapy, anti-targeted agents and immunotherapy
Chemotherapy, anti-targeted agents and immunotherapy

Radiation:
• Radiotherapy
Radiotherapy

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de A Coruña	A Coruña	La Coruña
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Vall d'Hebrón	Barcelona
Spain	Hospital General Universitario Santa Lucía	Cartagena	Murcia
Spain	Hospital General Universitario de Ciudad Real	Ciudad Real
Spain	Hospital Universitario Reina Sofia	Córdoba	Andalucía
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	Hospital General Universitario de Elda	Elda	Alicante
Spain	Hospital Universitario de Galdakao	Galdakao	Vizcaya
Spain	Hospital Universitario de Jaén	Jaén
Spain	Institut Català d'Oncologia	L'Hospitalet De Llobregat	Barcelona
Spain	Hospital San Pedro	Logroño	La Rioja
Spain	Hospital Central de la Defensa Gómez Ulla	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga	Andalucía
Spain	Hospital General Universitario Morales Meseguer	Murcia	Región De Murcia
Spain	Complejo Hospitalario Universitario de Ourense	Ourense
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Son Llàtzer	Palma De Mallorca	Islas Baleares
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Islas Baleares
Spain	Hospital Universitario de Navarra	Pamplona
Spain	Hospital Provincial de Pontevedra	Pontevedra
Spain	Hospital Universitari Parc Taulí	Sabadell	Barcelona
Spain	Complejo Asistencial Universitario de Salamanca	Salamanca
Spain	Hospital Universitario de Canarias	San Cristóbal de la Laguna	Santa Cruz De Tenerife
Spain	Hospital Universitario Nuestra Señora de la Candelaria	Santa Cruz De Tenerife
Spain	Hospital Universitario Marques de Valdecillas	Santander	Cantabria
Spain	Hospital Universitario Virgen del Rocio	Sevilla	Andalucía
Spain	Hospital Universitario Virgen Macarena	Sevilla	Andalucia
Spain	Hospital General Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Sociedad Española de Oncologia Médica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic and therapeutic approach	To evaluate survival (time in months) according to treatment of esophagogastric cancer in all stages, patients, and contexts.	Up to 12 months
Secondary	Epidemiological profiles	To know the epidemiological profiles of esophagogastric cancer in Spain: temporal and regional trends, morbidity, and mortality.	Up to 12 months
Secondary	Risk factors	To study risk factors associated with each subtype of esophagogastric cancer and localization.	Up to 12 months
Secondary	Pathological features	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
Secondary	Clinical and diagnostic approach	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
Secondary	Treatments adjusted to prognostic variables	To compare treatments adjusted to prognostic variables and baseline characteristics.	Up to 12 months
Secondary	Validate and compare prognostic models	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
Secondary	Prognostic factors	To analyze the prognostic factors in this population and build a predictive and/or prognostic model.	Up to 12 months
Secondary	Create and validate a predictive model	To create and validate a predictive model of early mortality.	Up to 12 months