Risk Assessment and Syndrome Evolution Models Combining Traditional Chinese Medicine and Modern Medicine Indicators for Chronic Atrophic Gastritis Malignant Transformation: a Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- malignant transformation events of chronic atrophic gastritis
研究概览
简要总结
Chronic atrophic gastritis (CAG) is acknowledged as the precancerous stage of gastric cancer (GC). The present study aims to developed risk assessment and syndrome evolution models of CAG malignant transformation events combining TCM indicators with modern medicine indicators. The proposed study is a registry study based participant survey conducted in 4 hospitals in Beijing, China. After obtaining informed consent, a total of 2000 study patients diagnosed with CAG will be recruited. 10-year follow-ups are carried out on-site in hospitals and off-site by telephone to track malignant transformation events.
详细描述
Chronic atrophic gastritis (CAG) is acknowledged as the precancerous stage of gastric cancer (GC). Active treatment of CAG is vital in arresting malignant transformation. Traditional Chinese medicine (TCM) has been widely used in treating CAG and preventing GC. To date, no study has been conducted to assess the risk and syndrome evolution features of CAG malignant transformation by establishing models combining both TCM and modern medicine indicators.
The present study aims to developed risk assessment and syndrome evolution models of CAG malignant transformation events combining TCM indicators with modern medicine indicators. The proposed study is a registry study based participant survey conducted in 4 hospitals in Beijing, China. After obtaining informed consent, a total of 2000 study patients diagnosed with CAG will be recruited. 10-year follow-ups are carried out on-site in hospitals and off-site by telephone to track malignant transformation events. Comparative analysis of prevalence of malignant transformation events and presenting TCM or modern medicine features in different groups is conducted using frequency analysis and chi-squared tests, and expressed with composition ratios. Correlation analysis of malignant transformation events and TCM or modern medicine factors will be performed using logistic regression, and multivariate Cox proportional hazard model respectively. Exploratory factor analysis, correspondence analysis, association rule analysis, hierarchical clustering analysis, and complex system entropy clustering analysis will also be performed respectively for validating features of syndrome evolution in CAG malignant transformation process.
Previous reports on modern medicine indicators based risk assessment model for ischemic stroke endpoint events exist, but no studies have been undertaken combining TCM features. The risk assessment model combining both TCM and modern medicine indicators has the potential to facilitate early warning, early intervention and early control of CAG malignant transformation. The syndrome evolution model will help evaluate the core TCM pathogenesis of CAG malignant transformation so as to promote optimization of treatment strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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) 18-75 years of age; (2) Meeting diagnostic criteria of CAG after upper gastrointestinal endoscopy; (3) Willing to cooperate with data, tissue sample, and blood sample collection during recruitment; (4) Willing to respond truthfully and timely to researcher queries after recruitment, able to cooperate with data, tissue sample and blood sample collection during follow-ups; (5) Willing to sign informed consent.
排除标准
- •(1) Meeting past history of previous stomach surgery; (2) Unable to participate in data, tissue sample or blood sample collection for any reason.
结局指标
主要结局
malignant transformation events of chronic atrophic gastritis
时间窗: 10 years follow-up
The primary outcome measures will be the malignant transformation events of chronic atrophic gastritis, including gastric mucosal atrophy, intestinal metaplasia, gastric intraepithelial dysplasia, and gastric carcinoma, according to the definition given by "Chronic Gastritis Diagnosis and Treatment Consensus of China (version 2012)", as promulgated by the Society of Gastroenterology, Chinese Medical Association.
次要结局
未报告次要终点
研究者
Dr. Xia Ding
Professor
Beijing University of Chinese Medicine
