New strategies for 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.
This study is trying to find better ways to spot and prevent gastric cancer early by looking at patients with the disease, those at risk, and healthy people in Spain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacion Miguel Servet Academic / other |
| Locations | 15 sites (Palma de Mallorca, Balearic Islands and 14 other locations) |
| Trial ID | NCT05551416 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective cohort study aims to enroll at least 600 patients diagnosed with primary gastric cancer, around 50 patients with premalignant gastric lesions, and 600 healthy participants in Spain. The study will collect clinical data and biological samples to evaluate clinical, endoscopic, and molecular approaches for identifying individuals at high risk for gastric cancer. By utilizing advanced diagnostic tools and life habits surveys, the study seeks to implement preventive measures that could reduce mortality through early detection and intervention.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with either diagnosed gastric cancer, premalignant gastric lesions, or those undergoing diagnostic gastroscopy.
Not a fit: Patients with previous gastric surgery, contraindications for gastroscopy, or those with gastric neoplasms other than adenocarcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and prevention strategies for gastric cancer, potentially reducing mortality rates.
How similar studies have performed: Other studies have shown success in utilizing similar approaches for early detection of gastric cancer, indicating a promising avenue for this research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Palma de Mallorca, Balearic Islands and 14 other locations
- Hospital Comarcal de Inca — Palma de Mallorca, Balearic Islands, Spain (Recruiting)
- Hospital de Llevant — Porto Cristo, Balearic Islands, Spain (Recruiting)
- Hospital General de Granollers — Granollers, Barcelona, Spain (Recruiting)
- Consorci Sanitari de Terrassa — Terrassa, Barcelona, Spain (Recruiting)
- Hospital Santos Reyes — Aranda de Duero, Burgos, Spain (Recruiting)
- Hospital de Mérida — Mérida, Extremadura, Spain (Recruiting)
- Hospital Universitario de Ourense — Ourense, Galicia, Spain (Recruiting)
- Hospital Puerta de Hierro — Majadahonda, Madrid, Spain (Recruiting)
- Hospital Universitario de Navarra — Pamplona, Navarre, Spain (Recruiting)
- Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain (Recruiting)
- Hospital Clínic de Barcelona — Barcelona, Spain (Recruiting)
- Hospital Universitario de Burgos — Burgos, Spain (Recruiting)
- Hospital Josep Trueta — Girona, Spain (Recruiting)
- Hospital Clínico Universitario Lozano Blesa — Zaragoza, Spain (Recruiting)
- Hospital Universitario Miguel Servet — Zaragoza, Spain (Recruiting)
Study contacts
- Study coordinator: Leticia Moreira, MD, PhD
- Email: LMOREIRA@clinic.cat
- Phone: +34 932275400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.