Interventional Study Focused on Providing Personalised Health Recommendations to the General Population Through an Integrated AI Guided App as a Strategy for Gastric Cancer Prevention (AIDA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- H. pylori Eradication Therapy Recommendation
研究概览
简要总结
This clinical study aims to be used to implement and validate the AIDA tool in two phases:
- Phase 1: Risk stratification and personalised recommendations & Model development
- Phase 2: Mechanistic Model (Bioresource) development & testing
详细描述
The AIDA objective (project) is to develop and validate a multidisciplinary AI-powered assistant that helps clinicians diagnose precancerous inflammation, suggests personalised therapeutic strategies for medical treatment and follow-up, and makes personalised recommendations for monitoring patient health status, thus contributing to gastric cancer prevention. This prospective clinical study aims to implement and validate such tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects ≥ 18 years old with a diagnosis of GIM or previous or current H. pylori infection, to whom a gastroscopy is indicated within clinical care
- •Availability of a signed informed consent form to participate in the study
排除标准
- •Patients to whom an endoscopy is performed for the follow-up of another illness such as oesophageal varices and/or for therapy such as endoscopic dilation, feeding tube placement or endoscopic resection
- •Subjects with a clinical diagnosis of gastric diseases other than GIM or GC
- •Patients who have received antimicrobials during the four weeks prior to the endoscopy
- •Patients who have received proton pump inhibitors and/or bismuth-based treatments at least two weeks prior to the endoscopy
- •Subjects for whom clinical data are not available: H. pylori status, eradication treatment, sex, age, tobacco smoking, and first-degree family history of gastric cancer
- •Subjects who lack the mental capacity to understand the nature and requirements of the study and who lack the ability to give informed consent
研究组 & 干预措施
Healthy controls
Subjects will be recruited prospectively from the Digestive Medicine/Endoscopy Departments of the centres involved. Patients will be treated according to the medical and patient decisions according to the clinical practice protocols of each site. Sample collection will be performed during a gastroscopy for pathological and molecular characterisation. This gastroscopy will be always indicated within usual clinical practice, so no additional risk is planned for the subjects included.
Inclusion criteria: Subjects ≥18 years old to whom an endoscopy is performed due to gastric symptoms, without previous history of gastric chronic inflammation or Helicobacter pylori infection
Gastric cancer controls
Subjects will be recruited prospectively from the Digestive Medicine/Endoscopy Departments of the centres involved. Patients will be treated according to the medical and patient decisions according to the clinical practice protocols of each site. Sample collection will be performed during a gastroscopy for pathological and molecular characterisation. This gastroscopy will be always indicated within usual clinical practice, so no additional risk is planned for the subjects included.
Inclusion criteria: Subjects ≥18 years old with a diagnosis of Gastric Cancer, to whom a gastroscopy is indicated within clinical care naive for chemotherapy.
GIM cases
Subjects will be recruited prospectively from the Digestive Medicine/Endoscopy Departments of the centres involved. Patients will be treated according to the medical and patient decisions according to the clinical practice protocols of each site. Sample collection will be performed during a gastroscopy for pathological and molecular characterisation. This gastroscopy will be always indicated within usual clinical practice, so no additional risk is planned for the subjects included.
Inclusion criteria: Subjects ≥18 years old with a diagnosis of GIM or previous or current H. pylori infection, to whom a gastroscopy is indicated within clinical care
干预措施: Health reccommendations (Behavioral)
结局指标
主要结局
H. pylori Eradication Therapy Recommendation
时间窗: From 30 days after the H.Pylori positive test result to one year after the first recommendation
AI driven H. pylori Eradication Therapy Recommendation
GIM risk score assessment using imaging modalities
时间窗: At the recruitment stage
AI driven GIM risk score assessment of pre-cancerous lesions using imaging modalities based on: QLQ C30 and STO22 EORTC questionnaire, Healthy lifestyle questionnaire (adapted from EPICs), Baseline clinical data, If H. pylori positive: adherence to treatment: yes/no; eradication yes/no, If GIM: adherence to follow-up guidelines yes/no
Risk of developing Gastric Cancer based on medical records
时间窗: At the recruitment stage
Scoring patients as low (\>30) / medium / high risk (\<6) according to: * Degree of 'healthiness' of lifestyle (1 to 10, with 10 as very low and 10 as very high) * Co-morbidities (Yes = 1 / No = 5) * H. pylori infection history (Yes = 1 / No = 5) * Previous gastric intestinal metaplasia (Yes = 1 / No = 5) * Dysplasia or atrophy related to chronic gastritis (Yes = 1 / No = 5) * Family history of cancer (Yes = 1 / No = 5)
次要结局
未报告次要终点