NCT05551416

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Sep 2021Dec 2026

Study Start

First participant enrolled

September 9, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

4.1 years

First QC Date

September 6, 2022

Last Update Submit

October 23, 2023

Conditions

Gastric NeoplasmsGastric CancerGastric Lesion

Keywords

Gastric CancerPremalignant gastric lesionsBiomarkersPrevalenceEndoscopyMultiomics

Outcome Measures

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.

    Up to 10 years

Secondary Outcomes (6)

  • Prevalence of premalignant gastric lesions (PGLs)

    Up to 5 years

  • Endoscopic characterization of PGLs

    Up to 5 years

  • Identification of GC hereditary predisposition by a customize multigene panel

    Up to 5 years

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

    Up to 5 years

  • Discover and validation of new biomarkers for early diagnosis of GC

    Up to 5 years

  • +1 more secondary outcomes

Study Arms (4)

EPIGASTRIC

Patients with GC.

Other: Identification of risk factorsOther: Identification of biomarkersOther: Identification of gastric cancer hereditary predisposition

EDGAR 1

Symptomatic patients subjected to a diagnostic gastroscopy to study the prevalence of premalignant gastric lesions.

Other: Identification of risk factorsOther: Characterization of premalignant gastric lesionsOther: Identification of biomarkers

EDGAR 2

Patients with premalignant gastric lesions and early gastric neoplasias treated by endoscopy resection.

Other: Identification of risk factorsOther: Characterization of premalignant gastric lesionsOther: Identification of biomarkers

Negative control

Patients from "EDGAR 1" without gastric pathology or familial history of this neoplasia.

Other: Identification of risk factorsOther: Identification of biomarkers

Interventions

Identification of risk factorsOTHER

Demographics, life habits and risk factors studies

EDGAR 1EDGAR 2EPIGASTRICNegative control
Characterization of premalignant gastric lesionsOTHER

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

EDGAR 1EDGAR 2
Identification of biomarkersOTHER

Multiomic studies

EDGAR 1EDGAR 2EPIGASTRICNegative control
Identification of gastric cancer hereditary predispositionOTHER

Genomic studies for the identification of individuals with hereditary GC predisposition

EPIGASTRIC

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIn accordance with both ministerial and European guidelines on the assessment of the gender dimension in biomedical research, and given the differential incidence between both sexes in relation to gastric cancer, we will carry out differential analyzes by sex in all work packages. They will especially be carried out in biomarkers and risk factors studies, in order to understand the influence of sex in the early diagnosis of gastric cancer. We estimate that the collection of cases of gastric cancer will be double in males, although in the EDGAR 1 cohort that will study the prevalence of premalignant gastric lesions, we will try to obtain balanced data for both sexes.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

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

Related Publications (2)

  • Herrera-Pariente C, Montori S, Llach J, Bofill A, Albeniz E, Moreira L. Biomarkers for Gastric Cancer Screening and Early Diagnosis. Biomedicines. 2021 Oct 12;9(10):1448. doi: 10.3390/biomedicines9101448.

    PMID: 34680565BACKGROUND

  • Herrera-Pariente C, Capo-Garcia R, Diaz-Gay M, Carballal S, Munoz J, Llach J, Sanchez A, Bonjoch L, Arnau-Collell C, Soares de Lima Y, Golubicki M, Jung G, Lozano JJ, Castells A, Balaguer F, Bujanda L, Castellvi-Bel S, Moreira L. Identification of New Genes Involved in Germline Predisposition to Early-Onset Gastric Cancer. Int J Mol Sci. 2021 Jan 28;22(3):1310. doi: 10.3390/ijms22031310.

    PMID: 33525650BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Nucleic acids and proteins will be obtained from the biological samples.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Leticia Moreira, MD, PhD

CONTACT

+34 932275400LMOREIRA@clinic.cat

Eduardo Albéniz, MD, PhD

CONTACT

+34 848420370ealbenia@navarra.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 22, 2022

Study Start

September 9, 2021

Primary Completion

September 30, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

October 24, 2023

Record last verified: 2023-10

Locations

ES(15)