Spanish Registry of Esophagogastric Cancer

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Patient data will be collected from medical records retrospectively.

Official Title
-----------------
AGAMENON-SEOM Study: Spanish Registry of Esophagogastric Cancer

Conditions
-----------------
Esophageal Cancer, Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: Surgery
* Drug: Chemotherapy, anti-targeted agents and immunotherapy
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Resectable non-advanced cancer | Procedure: Surgery<br>* Surgery<br>Drug: Chemotherapy, anti-targeted agents and immunotherapy<br>* Chemotherapy, anti-targeted agents and immunotherapy<br>Radiation: Radiotherapy<br>* Radiotherapy<br>|
| Cohort 2<br>Unresectable advanced cancer | Procedure: Surgery<br>* Surgery<br>Drug: Chemotherapy, anti-targeted agents and immunotherapy<br>* Chemotherapy, anti-targeted agents and immunotherapy<br>Radiation: Radiotherapy<br>* Radiotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiological profiles | To know the epidemiological profiles of esophagogastric cancer in Spain: temporal and regional trends, morbidity, and mortality. | Up to 12 months | 
| Risk factors | To study risk factors associated with each subtype of esophagogastric cancer and localization. | 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. | 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. | Up to 12 months | 
| Treatments adjusted to prognostic variables | To compare treatments adjusted to prognostic variables and baseline characteristics. | 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. | Up to 12 months | 
| Prognostic factors | 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 | To create and validate a predictive model of early mortality. | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric Cancer, Gastroesophageal junction cancer, Esophageal Cancer, Surgery, Chemotherapy, Radiotherapy, Antitargeted drug, Inmunotherapy