- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04958720
Spanish Registry of Esophagogastric Cancer (AGAMENON)
AGAMENON-SEOM Study: Spanish Registry of Esophagogastric Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
Study Locations
-
-
-
Alicante, Spain, 03010
- Recruiting
- Hospital General Universitario de Alicante
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Barcelona, Spain, 08003
- Recruiting
- Hospital del Mar
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Barcelona, Spain, 08035
- Recruiting
- Hospital Universitario Vall d'Hebron
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Barcelona, Spain, 08036
- Recruiting
- Hospital Clinic De Barcelona
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Barcelona, Spain, 08041
- Recruiting
- Hospital De La Santa Creu I Sant Pau
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Ciudad Real, Spain, 13005
- Recruiting
- Hospital General Universitario de Ciudad Real
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Jaén, Spain, 23007
- Recruiting
- Hospital Universitario de Jaén
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Madrid, Spain, 28034
- Recruiting
- Hospital Universitario Ramon y Cajal
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Madrid, Spain, 28041
- Recruiting
- Hospital Universitario 12 de Octubre
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Madrid, Spain, 28046
- Recruiting
- Hospital Universitario La Paz
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Madrid, Spain, 28040
- Recruiting
- Hospital Clinico San Carlos
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Madrid, Spain, 28007
- Recruiting
- Hospital General Universitario Gregorio Marañon
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Madrid, Spain, 28047
- Recruiting
- Hospital Central de la Defensa Gomez Ulla
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Ourense, Spain, 32005
- Recruiting
- Complejo Hospitalario Universitario de Ourense
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Pamplona, Spain, 31008
- Recruiting
- Hospital Universitario de Navarra
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Pontevedra, Spain, 36002
- Recruiting
- Hospital Provincial de Pontevedra
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Salamanca, Spain, 37007
- Recruiting
- Complejo Asistencial Universitario de Salamanca
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Santa Cruz De Tenerife, Spain, 38010
- Recruiting
- Hospital Universitario Nuestra Señora de la Candelaria
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Valencia, Spain, 46014
- Recruiting
- Hospital General Universitario de Valencia
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
Alicante
-
Elche, Alicante, Spain, 03203
- Recruiting
- Hospital General Universitario de Elche
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Elda, Alicante, Spain, 03600
- Recruiting
- Hospital General Universitario de Elda
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
Andalucia
-
Sevilla, Andalucia, Spain, 41009
- Recruiting
- Hospital Universitario Virgen Macarena
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
Andalucía
-
Córdoba, Andalucía, Spain, 14004
- Recruiting
- Hospital Universitario Reina Sofia
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Málaga, Andalucía, Spain, 29010
- Recruiting
- Hospital Regional Universitario de Malaga
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Sevilla, Andalucía, Spain, 41013
- Recruiting
- Hospital Universitario Virgen del Rocio
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
Asturias
-
Oviedo, Asturias, Spain, 33011
- Recruiting
- Hospital Universitario Central de Asturias
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
Barcelona
-
L'Hospitalet De Llobregat, Barcelona, Spain, 08908
- Recruiting
- Institut Catala d'Oncologia
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Sabadell, Barcelona, Spain, 08208
- Recruiting
- Hospital Universitari Parc Tauli
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
Cantabria
-
Santander, Cantabria, Spain, 39008
- Recruiting
- Hospital Universitario Marqués de Valdecillas
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
Islas Baleares
-
Palma De Mallorca, Islas Baleares, Spain, 07120
- Recruiting
- Hospital Universitario Son Espases
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
Palma De Mallorca, Islas Baleares, Spain, 07198
- Recruiting
- Hospital Son Llatzer
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
La Coruña
-
A Coruña, La Coruña, Spain, 15006
- Recruiting
- Complejo Hospitalario Universitario de A Coruña
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
La Rioja
-
Logroño, La Rioja, Spain, 26006
- Recruiting
- Hospital San Pedro
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
Madrid
-
Alcorcón, Madrid, Spain, 28922
- Recruiting
- Hospital Universitario Fundación Alcorcón
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
Murcia
-
Cartagena, Murcia, Spain, 30202
- Recruiting
- Hospital General Universitario Santa Lucía
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
Región de Murcia
-
Murcia, Región de Murcia, Spain, 30008
- Recruiting
- Hospital General Universitario Morales Meseguer
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
Santa Cruz de Tenerife
-
San Cristóbal de la Laguna, Santa Cruz de Tenerife, Spain, 38320
- Recruiting
- Hospital Universitario de Canarias
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
Vizcaya
-
Galdakao, Vizcaya, Spain, 48960
- Recruiting
- Hospital Universitario de Galdakao
-
Contact:
- Paula Dr Jiménez Fonseca, MD-PhD
- Phone Number: 36582 985106121
- Email: palucaji@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Investigators
- Principal Investigator: Paula Dr Jiménez Fonseca, MD-PhD, Sociedad Española de Oncología Médica (SEOM)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Stomach Neoplasms
- Esophageal Neoplasms
- Immunologic Factors
- Physiological Effects of Drugs
- Immunomodulating Agents
Other Study ID Numbers
- 2020-01
- RXSCXJ3E6E (Other Identifier: AEMPS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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