Risk Assessment and Syndrome Evolution Models for Chronic Atrophic Gastritis Malignant Transformation
1 other identifier
observational
2,000
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2017
CompletedFirst Posted
Study publicly available on registry
August 25, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
December 29, 2020
December 1, 2020
13 years
August 22, 2017
December 25, 2020
Conditions
Keywords
Outcome Measures
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.
10 years follow-up
Interventions
No intervention
Eligibility Criteria
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.
You may qualify if:
- (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.
You may not qualify if:
- (1) Meeting past history of previous stomach surgery; (2) Unable to participate in data, tissue sample or blood sample collection for any reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dongzhimen Hospital
Beijing, Beijing Municipality, 100029, China
Wangjing Hospital
Beijing, Beijing Municipality, 100102, China
Biospecimen
Paraffin section of gastric mucosa
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 22, 2017
First Posted
August 25, 2017
Study Start
January 1, 2018
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
December 29, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share