Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05551416
Status:
RECRUITING
Last Update Posted:
2023-10-24
First Post:
2022-09-06
Brief Title:
The EpiGASTRICEDGAR Project New Strategies for the Early Detection and Prevention of Gastric Cancer
Sponsor:
EDUARDO ALBENIZ
Organization:
Fundacion Miguel Servet
Study Overview
Official Title:
Research and Development of New Strategies for the Early Detection and Prevention of Gastric Cancer in the Spanish Population EpiGASTRICEDGAR Project
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor the reduction of its incidence
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 andor 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 78 cases per 100000 inhabitants being twice as frequent in men as in women During 2020 7577 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 andor the R software httpswwwr-projectorg will be used The differences between qualitative variables will be compared using Fishers 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 005 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 presenceprognosis of lesions that differentially affect subgroups of patients
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 andor the R software httpswwwr-projectorg will be used The differences between qualitative variables will be compared using Fishers 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 005 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 presenceprognosis of lesions that differentially affect subgroups of patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None