Clinical trial NCT03314038: Syndrome Patterns for Chronic Atrophic Gastritis Malignant Transformation
Official title: Validating Features of Traditional Chinese Syndrome Patterns for Chronic Atrophic Gastritis Malignant Transformation: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: TCM Syndrome of Chronic Atrophic Gastritis
Keywords: Chronic Atrophic Gastritis
Malignant Transformation
Syndrome
Traditional Chinese Medicine
Cross-sectional Study
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: The University of Science and Technology of China
name: China Academy of Chinese Medical Sciences
name: Harvard Medical School (HMS and HSDM)
First posted: 2017-10-19
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a multicenter cross-sectional study conducted in 4 hopitals in Beijing, China,lleaded by Beijing University of Chinese Medicine. According to the inclusion and exclusion criteria, 2000 eligible participants will be involved in this study.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: TCM syndrome
timeFrame: one time at involvement (1 day)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing University of Chinese Medicine
state: Beijing
Study officials:
affiliation: Beijing University of Chinese Medicine
name: Xia Ding, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Y, Liu Y, Song R, Zhang L, Su Z, Li Y, Chen R, Shi N, Zhao X, Du S, Ding X. Validating traditional Chinese syndrome features in varied stages of chronic gastritis malignant transformation: study protocol for a cross-sectional study. BMJ Open. 2018 Aug 30;8(8):e020939. doi: 10.1136/bmjopen-2017-020939.