About this trial
This study is a multicenter, prospective cohort study, which are planned to enroll at least 600 patients who diagnosed the primary gastric cancer (GC); around 50 patients with premalignant gastric lesions (PGLs) and early gastric neoplasias (EGC) treated by endoscopy resection; and no less than 600 healthy normal cohort participants, for more than 18 months in the Spanish population. All participants who enrolled in this registry will be questioned by the life habits survey; and clinical data and biological samples of these participants were analyzed in order to look for new diagnostic tools.
The aim of this study is to evaluate clinical, endoscopic and molecular approaches to identify individuals with high-risk of GC. Thus, it would be allow the adoption of preventive measures to reduce mortality through early detection and/or the reduction of its incidence.
Eligibility criteria
Qualifiers
Adults over 18 years-old.
EDGAR 1 cohort: symptomatic patients undergoing a diagnostic gastroscopy for a prevalence study of PGLs.
EDGAR 2 cohort: PGLs and early GC with indication for endoscopic resection.
EPIGASTRIC cohort: patients diagnosed with GC.
Disqualifiers
Refusal of the patient to participate in the study.
Medical, psychological or legal inability of the patient to enter the study.
EDGAR1: Previous diagnosis of PGLs, previous gastric surgery, contraindication for gastroscopy or taking biopsies.
EDGAR 2: Contraindication for resection/biopsy.
Trial design
Treatments tested in this trial
- Identification of risk factors
- Characterization of premalignant gastric lesions
- Identification of biomarkers
- Identification of gastric cancer hereditary predisposition
Treatment groups
Sponsors and collaborators
EDUARDO ALBENIZ
Lead sponsor
Fundacion Miguel Servet
Sponsor institution
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain
Collaborator
Fundació Clínic per a la Recerca Biomèdica (FCRB), Spain
Collaborator
Miguel Servet Foundation/Navarrabiomed, Spain
Collaborator
Hospital Clinic of Barcelona
Collaborator
Navarre University Hospital (HUN), Spain
Collaborator
Navarre Health Research Institute (IdiSNA), Spain
Collaborator
Carlos III Health Institute (ISCIII), Spain
Collaborator
Spanish Society of Digestive Endoscopy (SEED) Foundation
Collaborator
Spanish Association of Gastroenterology (AEG)
Collaborator