Risk Assessment and Syndrome Evolution Models for Chronic Atrophic Gastritis Malignant Transformation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorBeijing University of Chinese Medicine
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
This is a multicenter registry study conducted in 4 hopitals in Beijing, China, leaded by Beijing University of Chinese Medicine. According to the inclusion and exclusion criteria, 2000 eligible participants will be identified by screening CAG patients after beginning the study.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
10 years follow-upSponsors and contacts
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Beijing University of Chinese Medicine
Lead sponsor
The University of Science and Technology of China
Collaborator
China Academy of Chinese Medical Sciences
Collaborator
Harvard Medical School (HMS and HSDM)
Collaborator
Source ClinicalTrials.gov