Risk Assessment and Syndrome Evolution Models for Chronic Atrophic Gastritis Malignant Transformation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2030-12-31

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 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.

Detailed Description

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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.

Conditions

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Risk Assessment of Chronic Atrophic Gastritis Malignant Transformation

Keywords

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Chronic Atrophic Gastritis Malignant Transformation Risk Assessment Syndrome Evolution Traditional Chinese Medicine Registry Study

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Dr. Xia Ding

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dongzhimen Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Wangjing Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yin Zhang, MD

Role: CONTACT

Phone: 86-17710830835

Email: [email protected]

Xia Ding, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Ping Li, Dr.

Role: primary

Ping Zhang, Dr.