Esophageal CancerAGAMENONNCT04958720
Spanish Registry of Esophagogastric Cancer
An observational study of Esophageal Cancer and Gastric Cancer, run by Fundación Sociedad Española de Oncologia Médica at 38 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer
- What is being tested?
- Surgery, Chemotherapy, anti-targeted agents and immunotherapy and Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 38 sitesSpain
- Study dates
- 27 Apr 2020to 1 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- A patient for whom, for whatever reason, the information necessary to complete the database cannot be known or obtained.
Trial locations and contacts
38 sites in 1 country. Contact the study team or a site near you to ask about taking part.
38 sites in 1 country
Spain38 sites, 38 recruiting
- Recruiting
Complejo Hospitalario Universitario de A Coruña
A Coruña, La Coruña, 15006
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital General Universitario de Alicante
Alicante, Alicante, 03010
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital del Mar
Barcelona, Barcelona, 08003
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Vall d'Hebrón
Barcelona, Barcelona, 08035
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital General Universitario Santa Lucía
Cartagena, Murcia, 30202
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real, Ciudad Real, 13005
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital General Universitario de Elche
Elche, Alicante, 03203
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital General Universitario de Elda
Elda, Alicante, 03600
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario de Galdakao
Galdakao, Vizcaya, 48960
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario de Jaén
Jaén, Jaén, 23007
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08908
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital San Pedro
Logroño, La Rioja, 26006
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Central de la Defensa Gómez Ulla
Madrid, Madrid, 28047
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Regional Universitario de Málaga
Málaga, Andalusia, 29010
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital General Universitario Morales Meseguer
Murcia, Murcia, 30008
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Complejo Hospitalario Universitario de Ourense
Ourense, Ourense, 32005
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, 07198
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario de Navarra
Pamplona, Pamplona, 31008
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Provincial de Pontevedra
Pontevedra, Pontevedra, 36002
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitari Parc Taulí
Sabadell, Barcelona, 08208
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Complejo Asistencial Universitario de Salamanca
Salamanca, Salamanca, 37007
Paula Dr Jimenez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010
Paula Dr Jimenez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Marques de Valdecillas
Santander, Cantabria, 39008
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41009
Paula Dr Jimenez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013
Paula Dr Jimenez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Paula Dr Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
About this study
Official title: 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.
Read the detailed description
Patient data will be collected from medical records retrospectively.
- Conditions
- Esophageal Cancer, Gastric Cancer
- Being tested
- Surgery, Chemotherapy, anti-targeted agents and immunotherapy, Radiotherapy
- Keywords
- Gastric Cancer, Gastroesophageal junction cancer, Esophageal Cancer, Surgery, Chemotherapy, Radiotherapy, Antitargeted drug, Inmunotherapy
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Surgery
Chemotherapy, anti-targeted agents and immunotherapyDrug
Chemotherapy, anti-targeted agents and immunotherapy
RadiotherapyRadiation
Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Resectable non-advanced cancer Receives: Procedure: Surgery; Drug: Chemotherapy, anti-targeted agents and immunotherapy; Radiation: Radiotherapy | |
| Cohort 2 | Unresectable advanced cancer Receives: Procedure: Surgery; Drug: Chemotherapy, anti-targeted agents and immunotherapy; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic and therapeutic approach
To evaluate survival (time in months) according to treatment of esophagogastric cancer in all stages, patients, and contexts.
Measured: Up to 12 months
Secondary outcomes (8)
Epidemiological profiles
To know the epidemiological profiles of esophagogastric cancer in Spain: temporal and regional trends, morbidity, and mortality.
Measured: Up to 12 months
Risk factors
To study risk factors associated with each subtype of esophagogastric cancer and localization.
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
Treatments adjusted to prognostic variables
To compare treatments adjusted to prognostic variables and baseline characteristics.
Measured: Up to 12 months
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.
Measured: Up to 12 months
Prognostic factors
To analyze the prognostic factors in this population and build a predictive and/or prognostic model.
Measured: Up to 12 months
Create and validate a predictive model
To create and validate a predictive model of early mortality.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start27 Apr 2020
- Primary completion1 Dec 2034 (estimated)
- Study completion1 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Sociedad Española de Oncologia Médica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Dr Jiménez Fonseca, MD-PhD, Principal investigator, Sociedad Española de Oncología Medica (SEOM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958720
- Sponsor's protocol ID
- 2020-01
- Other IDs
- RXSCXJ3E6E
- Acronym
- AGAMENON
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2021
- Last updated
- 3 Jul 2025
- 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 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AGAMENON-SEOM Study: Spanish Registry of Esophagogastric Cancer
- ClinicalTrials.gov ID
- NCT04958720
- Acronym / sponsor ID
- AGAMENON / 2020-01
- Conditions
- Esophageal Cancer, Gastric Cancer
- Keywords
- Gastric Cancer, Gastroesophageal junction cancer, Esophageal Cancer, Surgery, Chemotherapy, Radiotherapy, Antitargeted drug, Inmunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Fundación Sociedad Española de Oncologia MédicaUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 1 Dec 2034 (estimated)
- Study completion
- 1 Dec 2035 (estimated)
- First posted
- 12 Jul 2021 (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.
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.
Detailed description
Patient data will be collected from medical records retrospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Procedure: Surgery, Drug: Chemotherapy, anti-targeted agents and immunotherapy, Radiation: RadiotherapyResectable non-advanced cancer |
| Cohort 2 | – | Procedure: Surgery, Drug: Chemotherapy, anti-targeted agents and immunotherapy, Radiation: RadiotherapyUnresectable advanced cancer |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- A patient for whom, for whatever reason, the information necessary to complete the database cannot be known or obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgerySurgery | Procedure or surgery | Cohort 1, Cohort 2 |
| Chemotherapy, anti-targeted agents and immunotherapyChemotherapy, anti-targeted agents and immunotherapy | Drug | Cohort 1, Cohort 2 |
| RadiotherapyRadiotherapy | Radiation | Cohort 1, Cohort 2 |
Primary outcome
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.
8 secondary outcomes
Epidemiological profiles
Time frame: Up to 12 months
Risk factors
Time frame: Up to 12 months
Pathological features
Time frame: Up to 12 months
Clinical and diagnostic approach
Time frame: Up to 12 months
Treatments adjusted to prognostic variables
Time frame: Up to 12 months
Validate and compare prognostic models
Time frame: Up to 12 months
Prognostic factors
Time frame: Up to 12 months
Create and validate a predictive model
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- 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.
Paula Dr Jiménez Fonseca, MD-PhD principal investigator
Sociedad Española de Oncología Medica (SEOM)
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Gastric Cancer, run by Fundación Sociedad Española de Oncologia Médica at 38 sites in Spain.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paula Dr Jiménez Fonseca, MD-PhD (985106121 ext. 36582, palucaji@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic and therapeutic approach (time frame: Up to 12 months). 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 3 Jul 2025.