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

ConditionsGastric NeoplasmsGastric CancerGastric Lesion
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

This trial does not accept healthy volunteers

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 population

This cohort study is designed to enroll the Spanish population patients who are diagnosed gastric cancer; symptomatic patients subjected to a diagnostic gastroscopy who have or not premalignant gastric lesions and early gastric neoplasias susceptible to be treated by endoscopy resection; and healthy control participants by multicenter-prospective registry. Nevertheless, the study will be open to international participation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Identification of risk factors

    Other intervention

    Demographics, life habits and risk factors studies

  • Characterization of premalignant gastric lesions

    Other intervention

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

  • Identification of biomarkers

    Other intervention

    Multiomic studies

  • Identification of gastric cancer hereditary predisposition

    Other intervention

    Genomic studies for the identification of individuals with hereditary GC predisposition

Treatment groups

1,200 Participants
are divided into 4 treatment groups
Group A: EPIGASTRIC3 interventions
Group B: EDGAR 13 interventions
Group C: EDGAR 23 interventions
Group D: Negative control2 interventions

Trial outcomes

Primary outcomes

1

New strategies for gastric cancer (GC) early diagnosis

Prediction of risk factors and identification of new strategies for an early diagnosis of GC.

Time frame
Up to 10 years

Secondary outcomes

1

Prevalence of premalignant gastric lesions (PGLs)

Determine the prevalence of PGLs in the EDGAR 1 cohort.

Time frame
Up to 5 years
2

Endoscopic characterization of PGLs

Identification and characterization of PGLs through high definition endoscopic study, testing the concordance between endoscopic and histological classifications.

Time frame
Up to 5 years
3

Identification of GC hereditary predisposition by a customize multigene panel

Define de most effective strategy for the identification of individuals with hereditary GC predisposition. In order to perform a clinical validation of the candidate genes identified by whole exome sequencing according to previous results of the research team (Herrera-Pariente, et al. IJMS 2021), a customize multigene panel has been designed including 25 potentially germline genetic variants associated to hereditary GC and 13 genes already associated with a higher risk of GC. This panel has been already tested, by the research group, ensuring its viability.

Time frame
Up to 5 years
4

Identification of GC risk factors from clinical data and a lifestyle survey

Based on the endoscopic classifications of the lesions found, the demographic data of the patient and their lifestyle and diet habits obtained through a specific questionnaire, risk factors involved in the development of CG will be identified through logistic regression. The identified risk factors will be used to create a predictive model.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov
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