Association of Microplastic Exposure With Pathological Stages of Gastric Mucosal Carcinogenesis: A Cross-Sectional Study
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
- Correlation between external exposure levels of microplastics and three pathological stages of gastric mucosal carcinogenesis
研究概览
简要总结
The objective of this clinical trial is to explore the correlation between the level of microplastic exposure and the risk of gastric mucosal carcinogenesis, and to evaluate the strength of its effect as an independent risk factor. The main questions it aims to answer include: Does the level of microplastic exposure increase the risk of gastric mucosal carcinogenesis? Can the correlation between the level of microplastic exposure and gastric mucosal carcinogenesis, as well as the sources of high - risk microplastic exposure, be explored through a questionnaire on external microplastic exposure? Researchers will complete a design structured questionnaire and ask participants to fill it out carefully and truthfully to determine whether the level of microplastic exposure increases the risk of gastric mucosal carcinogenesis.
详细描述
The study will categorize participants into three groups based on endoscopic and/or histopathological findings: chronic non-atrophic gastritis, precancerous lesions, and gastric cancer. Basic demographic information, *Helicobacter pylori* infection status, and plastic exposure assessment scores will be recorded for each group.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Aged between 18 and 75 years old, gender is not restricted; (2) Having a clear diagnosis result within the recent three months and being diagnosed with chronic non - atrophic gastritis, precancerous lesions of gastric cancer, or gastric cancer for the first time; (3) Have clear Helicobacter pylori (Hp) test results (including 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test); (4) Be in normal mental state and able to independently complete the questionnaire survey.
排除标准
- •Patients with a history of malignant tumors in other parts;
- •Patients who have previously undergone upper gastrointestinal surgery, chemotherapy, or radiotherapy;
- •Patients with severe diseases of major organs such as the heart, lungs liver, and kidneys;
- •Patients who are currently receiving psychological intervention or taking psychiatric drugs;
- •Pregnant or lactating women;
- •Patients with severe missing clinical data or questionnaire information;
- •Refusing to sign the informed consent form -
研究组 & 干预措施
precancerous lesion
Patients with chronic atrophic gastritis, gastric intestinal metaplasia, and gastric intraepithelial neoplasia based on endoscopic and/or histopathological results
Chronic non-atrophic gastritis
Patients diagnosed with chronic non-atrophic gastritis based on endoscopic and/or histopathological results
gastric cancer
patients with gastric cancer according to endoscopic and/or histopathological results
结局指标
主要结局
Correlation between external exposure levels of microplastics and three pathological stages of gastric mucosal carcinogenesis
时间窗: 9 months
The investigators evaluated the correlation between external exposure to microplastics and the three pathological stages of gastric mucosal carcinogenesis based on the patients' final diagnosis results and the completed questionnaires they filled out.
次要结局
- Analysis of sources of high - risk microplastic exposure(9 months)
- Synergistic toxicity of microplastics and Helicobacter pylori(9 months)
研究者
Yongquan Shi
Professor
Xijing Hospital of Digestive Diseases