The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEDUARDO ALBENIZ

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

1,200 Participants
are divided into 4 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