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

NCT05551416 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2023-10-24

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Identification of risk factors

Demographics, life habits and risk factors studies

OTHER

Characterization of premalignant gastric lesions

Identification and characterization of premalignant gastric lesions through high definition endoscopic study. Concordance between endoscopic and histological classifications

OTHER

Identification of biomarkers

Multiomic studies

OTHER

Identification of gastric cancer hereditary predisposition

Genomic studies for the identification of individuals with hereditary GC predisposition

Sponsors & Collaborators

  • Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain

    collaborator UNKNOWN
  • Fundació Clínic per a la Recerca Biomèdica (FCRB), Spain

    collaborator UNKNOWN
  • Miguel Servet Foundation/Navarrabiomed, Spain

    collaborator UNKNOWN
  • Barcelona Clinic Hospital (HCB), Spain

    collaborator UNKNOWN
  • Navarre University Hospital (HUN), Spain

    collaborator UNKNOWN
  • Navarre Health Research Institute (IdiSNA), Spain

    collaborator UNKNOWN
  • Carlos III Health Institute (ISCIII), Spain

    collaborator UNKNOWN
  • Spanish Society of Digestive Endoscopy (SEED) Foundation

    collaborator UNKNOWN
  • Spanish Association of Gastroenterology (AEG)

    collaborator UNKNOWN
  • EDUARDO ALBENIZ

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2025-09-30
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05551416 on ClinicalTrials.gov