跳至主要内容
临床试验/NCT05551416
NCT05551416招募中不适用

Research and Development of New Strategies for the Early Detection and Prevention of Gastric Cancer in the Spanish Population: EpiGASTRIC/EDGAR Project.

EDUARDO ALBENIZ15 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2021年9月9日最近更新:
适应症

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:

  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:

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

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

发起方
EDUARDO ALBENIZ
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

EDUARDO ALBENIZ

MD, PhD

Fundacion Miguel Servet

研究点 (15)

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