The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
Research and Development of New Strategies for the Early Detection and Prevention of Gastric Cancer in the Spanish Population: EpiGASTRIC/EDGAR Project.
EDUARDO ALBENIZ
1,200 participants
Sep 9, 2021
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria5
- 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.
- CONTROL cohort: patients without gastric pathology or a familial history of GC, obtained from the EDGAR 1.
Exclusion Criteria5
- 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.
- EPIGASTRIC: gastric neoplasm other than adenocarcinoma.
Interventions
Demographics, life habits and risk factors studies
Identification and characterization of premalignant gastric lesions through high definition endoscopic study. Concordance between endoscopic and histological classifications
Multiomic studies
Genomic studies for the identification of individuals with hereditary GC predisposition
Locations(15)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05551416