Different Endoscopic Gastric Cancer Risk Assessments
1 other identifier
interventional
3,500
1 country
1
Brief Summary
The Kimura-Takamoto classification established in Japan can observe the extent of gastric atrophy in real-time under endoscopy, and diffuse atrophy also indicates an increased risk of gastric cancer. Recent studies have found that the evaluation of intestinal metaplasia score (EGGIM score) of various stomach parts by electronic staining can well identify OLGIM III\\ IV patients. Although the Kimura-Takamoto classification and EGGIM score can evaluate the risk of gastric cancer in patients, only in cross-sectional studies, it is not clear the diagnostic value of risk assessment in population screening. Early gastric cancer has the characteristics of hidden lesions and a high rate of clinical missed diagnosis. Concentrating high-risk groups through risk scores is expected to guide endoscopic doctors to conduct a targeted careful examination. However, it is not clear whether Kimura-Takamoto classification and EGGIM score can improve the detection rate of early gastric cancer in clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Typical duration for not_applicable
1 active site
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
July 11, 2022
CompletedStudy Start
First participant enrolled
July 12, 2022
CompletedFirst Posted
Study publicly available on registry
July 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2025
CompletedJuly 14, 2022
July 1, 2022
2.5 years
July 11, 2022
July 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Early gastric cancer detection rate
The detection rate of early gastric cancer
36 months
Study Arms (2)
Kimura-Takemoto classification
ACTIVE COMPARATOREGGIM
ACTIVE COMPARATORInterventions
All patients were given two risk scores, the order of which was randomly determined.
All patients were given two risk scores, the order of which was randomly determined.
Eligibility Criteria
You may qualify if:
- Patients aged 40-80 years undergoing gastroscopy
- Patients intend to undergo ESD treatment
You may not qualify if:
- patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
- Patients with previous surgical procedures on the stomach
- patients with contraindications to biopsy
- Patients who refuse to sign the informed consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yanqing Lilead
Study Sites (1)
Qilu Hospital, Shandong University
Jinan, Shandong, 250001, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Vice President of Qilu Hospital
Study Record Dates
First Submitted
July 11, 2022
First Posted
July 14, 2022
Study Start
July 12, 2022
Primary Completion
December 31, 2024
Study Completion
July 4, 2025
Last Updated
July 14, 2022
Record last verified: 2022-07