Research and Development of New Strategies for the Early Detection and Prevention of Gastric Cancer in the Spanish Population: EpiGASTRIC/EDGAR Project.

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Santos Reyes
RECRUITING
Aranda De Duero
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Universitario de Burgos
RECRUITING
Burgos
Hospital Josep Trueta
RECRUITING
Girona
Hospital General de Granollers
RECRUITING
Granollers
Hospital Puerta de Hierro
RECRUITING
Majadahonda
Hospital de Mérida
RECRUITING
Mérida
Hospital Universitario de Ourense
RECRUITING
Ourense
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital Comarcal de Inca
RECRUITING
Palma De Mallorca
Hospital Universitario de Navarra
RECRUITING
Pamplona
Hospital de Llevant
RECRUITING
Porto Cristo
Consorci Sanitari de Terrassa
RECRUITING
Terrassa
Hospital Clínico Universitario Lozano Blesa
RECRUITING
Zaragoza
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Leticia Moreira, MD, PhD
LMOREIRA@clinic.cat
+34 932275400
Backup
Eduardo Albéniz, MD, PhD
ealbenia@navarra.es
+34 848420370
Time Frame
Start Date: 2021-09-09
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 1200
Treatments
EPIGASTRIC
Patients with GC.
EDGAR 1
Symptomatic patients subjected to a diagnostic gastroscopy to study the prevalence of premalignant gastric lesions.
EDGAR 2
Patients with premalignant gastric lesions and early gastric neoplasias treated by endoscopy resection.
Negative control
Patients from EDGAR 1 without gastric pathology or familial history of this neoplasia.
Related Therapeutic Areas
Sponsors
Collaborators: Barcelona Clinic Hospital (HCB), Spain, Carlos III Health Institute (ISCIII), Spain, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain, Navarre Health Research Institute (IdiSNA), Spain, Spanish Association of Gastroenterology (AEG), Navarre University Hospital (HUN), Spain, Miguel Servet Foundation/Navarrabiomed, Spain, Fundació Clínic per a la Recerca Biomèdica (FCRB), Spain, Spanish Society of Digestive Endoscopy (SEED) Foundation
Leads: EDUARDO ALBENIZ

This content was sourced from clinicaltrials.gov