Risk assessment models of integrative medicine indicators for malignant transformation of chronic atrophic gastritis: A registry study protocol

Traditional Chinese medicine (TCM) and modern medicine have both been used in arresting malignant transformation of chronic atrophic gastritis (CAG) in China with good therapeutic effect. However, no studies have been undertaken to assess the risk of malignant transformation in CAG patients using both modern medicine and TCM features. Our study aimed to develop risk assessment models for malignant transformation of CAG combining indicators of both TCM and modern medicine. These models will facilitate early warning and control of malignant transformation of CAG from the perspective of evidence-based integrative medicine.

In the proposed registry study, a total of 1000 eligible CAG patients will be recruited from four hospitals in China. A 10-year follow-up study will be conducted both on-site and off-site to track the events of malignant transformation. Frequency analysis and chi-squared tests will be used to perform the comparative analysis on the prevalence of malignant transformation events and indicators in TCM or modern medicine in different groups. A multivariate Cox proportional hazard model will be used to perform correlation analyses of malignant transformation events and factors of TCM or modern medicine.

The proposed study has been designed with a large sample size and long follow-up period, in which wide-ranging modern medicine and TCM indicators can be gathered over the whole process of malignant transformation of CAG. Based on this study, risk assessment models for malignant transformation of CAG may be constructed from the perspective of integrative medicine. This may provide clinicians and patients with an optimized early warning system as well as prevention strategies for malignant transformation of CAG.