Research and Development of New Strategies for the Early Detection and Prevention of Gastric Cancer in the Spanish Population: EpiGASTRIC/EDGAR Project.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 15
- 主要终点
- New strategies for gastric cancer (GC) early diagnosis
研究概览
简要总结
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.
详细描述
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:
- "EDGAR 1": symptomatic patients undergoing a diagnostic gastroscopy to study the prevalence of PGLs;
- "EDGAR 2": PGLs and EGC with indication for endoscopic resection;
- "EPIGASTRIC": patients diagnosed with GC;
- 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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
New strategies for gastric cancer (GC) early diagnosis
时间窗: Up to 10 years
Prediction of risk factors and identification of new strategies for an early diagnosis of GC.
次要结局
- Prevalence of premalignant gastric lesions (PGLs)(Up to 5 years)
- Endoscopic characterization of PGLs(Up to 5 years)
- Discover and validation of new biomarkers for early diagnosis of GC(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)
- Characterization of the microbiome: 16S rRNA studies(Up to 5 years)
研究者
EDUARDO ALBENIZ
MD, PhD
Fundacion Miguel Servet
