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Clinical Trials in China / NCT03261934
Recruiting Observational

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

NCT03261934 · tracked via the Priya Life Science China tracker
Sponsor
Beijing University of Chinese Medicine
Phase
Observational
Started
2018-01-01
Last updated
2020-12-29

Condition(s) studied

Risk Assessment of Chronic Atrophic Gastritis Malignant Transformation

Investigational drug(s) / intervention(s)

No intervention

No intervention: No intervention

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)

  • malignant transformation events of chronic atrophic gastritis — 10 years follow-up
    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.

Trial sites (2)

FacilityCityRegionStatus
Dongzhimen Hospital Beijing Beijing Municipality Recruiting
Wangjing Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03261934 on ClinicalTrials.gov ↗ ← All trials in China