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

Risk Assessment of Chronic Atrophic Gastritis Malignant Transformation Clinical Trial

Official title:

Risk Assessment and Syndrome Evolution Models Combining Traditional Chinese Medicine and Modern Medicine Indicators for Chronic Atrophic Gastritis Malignant Transformation: a Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03261934
• Other study ID #: 81630080-CAG-REG
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2030

Study information

• Verified date: December 2020
• Source: Beijing University of Chinese Medicine
• Contact: Yin Zhang, MD
• Phone: 86-17710830835
• Email: coolzhangyin[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Gastritis
• Gastritis, Atrophic
• Risk Assessment of Chronic Atrophic Gastritis Malignant Transformation

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Dongzhimen Hospital	Beijing	Beijing
China	Wangjing Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Beijing University of Chinese Medicine	China Academy of Chinese Medical Sciences, Harvard Medical School, The University of Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	malignant transformation events of chronic atrophic gastritis	The primary outcome measures will be the malignant transformation events of chronic atrophic gastritis, including gastric mucosal atrophy, intestinal metaplasia, gastric intraepithelial dysplasia, and gastric carcinoma, according to the definition given by "Chronic Gastritis Diagnosis and Treatment Consensus of China (version 2012)", as promulgated by the Society of Gastroenterology, Chinese Medical Association.	10 years follow-up