Trial Title:
The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
NCT ID:
NCT05551416
Condition:
Gastric Neoplasms
Gastric Cancer
Gastric Lesion
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Gastric Cancer
Premalignant gastric lesions
Biomarkers
Prevalence
Endoscopy
Multiomics
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Identification of risk factors
Description:
Demographics, life habits and risk factors studies
Arm group label:
EDGAR 1
Arm group label:
EDGAR 2
Arm group label:
EPIGASTRIC
Arm group label:
Negative control
Intervention type:
Other
Intervention name:
Characterization of premalignant gastric lesions
Description:
Identification and characterization of premalignant gastric lesions through high
definition endoscopic study. Concordance between endoscopic and histological
classifications
Arm group label:
EDGAR 1
Arm group label:
EDGAR 2
Intervention type:
Other
Intervention name:
Identification of biomarkers
Description:
Multiomic studies
Arm group label:
EDGAR 1
Arm group label:
EDGAR 2
Arm group label:
EPIGASTRIC
Arm group label:
Negative control
Intervention type:
Other
Intervention name:
Identification of gastric cancer hereditary predisposition
Description:
Genomic studies for the identification of individuals with hereditary GC predisposition
Arm group label:
EPIGASTRIC
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.
Detailed description:
Gastric cancer (GC) is the fifth most common and the third more deadly cancer in the
world. In Spain, the incidence is 7.8 cases per 100,000 inhabitants, being twice as
frequent in men as in women. During 2020, 7.577 new cases were diagnosed and
approximately 5201 deaths occurred (Spanish association against cancer, AECC). Most cases
are diagnosed in an advanced stage with a 5-year survival rate lower than 30%, which
highlights the great importance of an early diagnosis.
Thus, this study aims to evaluate clinical, endoscopic and molecular approaches to
identify individuals with high-risk of GC.
Methods: Coordinate and prospective project that considers the gender dimension of
population-based study within a collaborative network. It includes different but
interrelated cohorts:
1. "EDGAR 1": symptomatic patients undergoing a diagnostic gastroscopy to study the
prevalence of PGLs;
2. "EDGAR 2": PGLs and EGC with indication for endoscopic resection;
3. "EPIGASTRIC": patients diagnosed with GC;
4. CONTROLS: patients without gastric pathology or a familial history of GC, obtained
from the cohort EDGAR1.
Although GC diagnosis has been characterized by endoscopy, there has been a strong demand
for low or non-invasive methods of GC detection. In this sense, clinical information and
biological samples obtained by less invasive methods will be collected prospectively from
the participating centers. State-of-the-art high-definition endoscopy and multiomic
techniques will be used to perform:
- Clinical studies: Study the prevalence of GC and PGLs and genetic and environmental
predisposing factors. Evaluation of high-definition endoscopy efficacy in the
detection of PGLs and EGC. Concordance between endoscopic and histological
classifications of PGLs. Estimate the risk of PGLs progression according to the
follow-up of the lesions. Identification of GC-high-risk individuals, based on
clinical data, familial factors, PGLs and a life habits survey.
- Translational studies: Identify and validate nucleic acids and proteins as new
biomarkers of GC and PGLs in biological samples obtained by low or non-invasive
methods and comparison with those obtained from histological samples and with the
traditional markers used in GC diagnosis.
Given the multicenter nature of this project, standard operating procedures (SOPs) have
also been established for the collection, processing, storage, and management of
biological samples, so that it is carried out in the same way in all participating
centers.
The data will be collected on the REDCap-AEG online platform, which can be accessed by
researchers from each center through an identification code, respecting the current
Organic Law on Data Protection. For patient registries, a specific database has been
designed for each subproject (EDGAR 1, EDGAR 2 and EPIGASTRIC). This guarantees the
quality of the data and allows its verification, as it defines, classifies and
illustrates the different parameters to be assessed by the participating researchers.
Finally, it allows the codification and anonymization of the data entered, which
guarantees compliance with the data protection law of this study.
Statistical analysis: The SPSS program (IBM, NY) and/or the R software
(https://www.r-project.org/) will be used. The differences between qualitative variables
will be compared using Fisher's test. The quantitative variables will be analyzed using a
non-parametric test (Mann-Whitney or Kruskall-Wallis for unpaired samples and Wilcoxon
for paired samples). A "p" value <0.05 will be considered statistically significant. All
the registered variables will be studied to determine their association with the
diagnosis by means of univariate and multivariate logistic regression analysis. In
addition, through an interaction study, we will evaluate whether there are risk factors
associated with the presence/prognosis of lesions that differentially affect subgroups of
patients.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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.
Gender:
All
Gender based:
Yes
Gender description:
In 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.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitario Central de Asturias
Address:
City:
Oviedo
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Eva Barreiro
Investigator:
Last name:
Adolfo Suárez
Email:
Sub-Investigator
Investigator:
Last name:
Pablo Florez
Email:
Sub-Investigator
Facility:
Name:
Hospital Comarcal de Inca
Address:
City:
Palma De Mallorca
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Silvia Patricia Ortega
Facility:
Name:
Hospital de Llevant
Address:
City:
Porto Cristo
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Gustavo O Patrón
Facility:
Name:
Hospital General de Granollers
Address:
City:
Granollers
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Beatriz De Riba
Facility:
Name:
Consorci Sanitari de Terrassa
Address:
City:
Terrassa
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Diana Zaffalon
Facility:
Name:
Hospital Santos Reyes
Address:
City:
Aranda De Duero
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Luis Hernández
Investigator:
Last name:
Raquel Grajal
Email:
Sub-Investigator
Facility:
Name:
Hospital de Mérida
Address:
City:
Mérida
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Pedro Delgado
Facility:
Name:
Hospital Universitario de Ourense
Address:
City:
Ourense
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Sara Zarraquiños
Facility:
Name:
Hospital Puerta de Hierro
Address:
City:
Majadahonda
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Alberto Herreros de Tejada
Facility:
Name:
Hospital Universitario de Navarra
Address:
City:
Pamplona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Eduardo Albéniz
Email:
ealbenia@navarra.es
Facility:
Name:
Hospital Clínic de Barcelona
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Leticia Moreira
Email:
LMOREIRA@clinic.cat
Investigator:
Last name:
Joan Llach
Email:
Sub-Investigator
Facility:
Name:
Hospital Universitario de Burgos
Address:
City:
Burgos
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Rosa M Saiz
Investigator:
Last name:
Gadea Hontoria
Email:
Sub-Investigator
Facility:
Name:
Hospital Josep Trueta
Address:
City:
Gerona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Virginia Piñol
Facility:
Name:
Hospital Clínico Universitario Lozano Blesa
Address:
City:
Zaragoza
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Gonzalo Hijos
Investigator:
Last name:
María José Domper
Email:
Sub-Investigator
Facility:
Name:
Hospital Universitario Miguel Servet
Address:
City:
Zaragoza
Country:
Spain
Status:
Recruiting
Contact:
Last name:
María Elena Arruebo
Start date:
September 9, 2021
Completion date:
December 31, 2026
Lead sponsor:
Agency:
EDUARDO ALBENIZ
Agency class:
Other
Collaborator:
Agency:
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain
Agency class:
Other
Collaborator:
Agency:
Fundació Clínic per a la Recerca Biomèdica (FCRB), Spain
Agency class:
Other
Collaborator:
Agency:
Miguel Servet Foundation/Navarrabiomed, Spain
Agency class:
Other
Collaborator:
Agency:
Barcelona Clinic Hospital (HCB), Spain
Agency class:
Other
Collaborator:
Agency:
Navarre University Hospital (HUN), Spain
Agency class:
Other
Collaborator:
Agency:
Navarre Health Research Institute (IdiSNA), Spain
Agency class:
Other
Collaborator:
Agency:
Carlos III Health Institute (ISCIII), Spain
Agency class:
Other
Collaborator:
Agency:
Spanish Society of Digestive Endoscopy (SEED) Foundation
Agency class:
Other
Collaborator:
Agency:
Spanish Association of Gastroenterology (AEG)
Agency class:
Other
Source:
Fundacion Miguel Servet
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05551416
