Syndrome Patterns for Chronic Atrophic Gastritis Malignant Transformation

Study Overview
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Brief Summary
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Chronic atrophic gastritis (CAG) is acknowledged as the precancerous stage of gastric cancer (GC). The present study aims to explore Traditional Chinese Medicine (TCM) syndrome features in different stages of CAG malignant transformation respectively. The proposed study is a cross-sectional study based participant survey conducted in 4 hospitals in Beijing, China. After obtaining informed consent, a total of 2000 study patients will be recruited on-site in hospitals.

Detailed Description
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CAG is acknowledged as the precancerous stage 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 in China. To date, few study has been conducted to assess the syndrome features of different stages of CAG malignant transformation combining TCM indicators. The present study aims to explore TCM syndrome features in different stages of CAG malignant transformation. 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 eligible study patients will berecruited on-site in hospitals. Comparative analysis of prevalence of presenting TCM features is conducted using frequency analysis and chi-squared tests, and expressed with composition ratios. Exploratory factor analysis,correspondence analysis, association rule analysis, hierarchical clustering analysis, and complex system entropy clustering analysis will be performed respectively for validating features of syndrome in different stages of CAG malignant transformation. Previous reports on TCM syndrome features for CAG exist, but no studies have been undertaken base on large-sampled study design and detailed analysis in different stages of CAG malignant transformation respectively. The outcome of our study has the potential to clerify core TCM pathogenesis of CAG, facilitate early intervention, and promote optimization of treatment strategies of CAG malignant transformation by TCM.

Official Title
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Validating Features of Traditional Chinese Syndrome Patterns for Chronic Atrophic Gastritis Malignant Transformation: A Cross-sectional Study

Conditions
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TCM Syndrome of Chronic Atrophic Gastritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (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. Exclusion Criteria: (1) Meeting past history of previous stomach surgery; (2) Unable to participate in data, tissue sample or blood sample collection for any reason.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TCM syndrome | According to the symptoms and physical signs of patients to determine the syndrome | one time at involvement (1 day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Atrophic Gastritis, Malignant Transformation, Syndrome, Traditional Chinese Medicine, Cross-sectional Study