Introduction The transition from chronic non-atrophic gastritis (CNAG) to chronic atrophic gastritis (CAG) and gastric carcinoma (GC) is regarded as a representative disease model of gastric mucosa malignant transformation led by uncontrolled inflammation. Traditional Chinese medicine (TCM) syndrome-targeted therapies have been applied in treating chronic gastritis (CG) malignant transformation in China with satisfying efficacy. This study aims to validate TCM syndrome features in each stage of CG malignant transformation. The findings may shed light on the TCM hypothesis of CG malignant transformation, and thus optimise syndrome-targeted treatment strategies of CNAG, CAG and GC, respectively.
Methods and analysis The present study is a cross-sectional study conducted in China. A total of 2000 eligible patients, including 500 CNAG cases, 1000 CAG cases and 500 GC cases, will be recruited from four TCM hospitals. Primary outcome measures include the prevalence of TCM syndrome patterns in varied stages of CG malignant transformation. Secondary outcome measures include prevalence and severity of all the presenting signs and symptoms collected by using TCM four diagnostic methods. Descriptive analysis, comparative analysis and correlation analysis of all the measurement data will be performed by biostatisticians. Unsupervised data mining analyses, including exploratory factor analysis, association rule analysis, hierarchical clustering analysis, complex system entropy clustering analysis, and so on, will also be performed by data scientists respectively for in-depth analyses of TCM syndrome-related indicators.
Ethics and dissemination The protocol has been approved by the Ethical Review Board of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine (No ECPJ-BDY-2014-02). All the study outcomes will be disseminated through national conference reports and in the meantime published on peer-reviewed journals.
Trial registration number NCT03314038; Pre-results.
- chronic gastritis
- malignant transformation
- traditional Chinese medicine
- cross-sectional study
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YZ, YL and RS contributed equally.
Contributors Study concept: XD. Study and statistical analysis design: XD, YZ, YL, RS and ZS. Drafting of the manuscript: YZ, YL and RS. Critical review and revisions of the manuscript: XD, LZ, YL, RC, NS, XZ and SD. YZ, YL and RS contributed equally to this work. The authors assume full responsibility for study design, programming, data analyses and interpretation of the outcomes. All authors approved the final version of the manuscript.
Funding This work was supported by the National Natural Science Foundation of China (No. 81630080, 91129714, 81270466, 30500183, 30870990, 81173424, 81373796, 81673793), National Undergraduates Innovating Experimentation Project of the Ministry of Education of China (No. 081002609), Research Foundation of the Doctoral Program of Higher Education of China (No. 20120013110014), and Science Research Foundation of BUCM (No. 2014-JYBZZ-XS-134).
Competing interests None declared.
Patient consent Not required.
Ethics approval Ethical Review Board of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine (No ECPJ-BDY-2014-02).
Provenance and peer review Not commissioned; externally peer reviewed.
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