Different Endoscopic Gastric Cancer Risk Assessments
Primary Purpose
Gastric Cancer Screening
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Kimura-Takemoto classification
EGGIM
Sponsored by
About this trial
This is an interventional screening trial for Gastric Cancer Screening
Eligibility Criteria
Inclusion Criteria:
- Patients aged 40-80 years undergoing gastroscopy
- Patients intend to undergo ESD treatment
Exclusion Criteria:
- 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.
Sites / Locations
- Qilu Hospital, Shandong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Kimura-Takemoto classification
EGGIM
Arm Description
Outcomes
Primary Outcome Measures
Early gastric cancer detection rate
The detection rate of early gastric cancer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05458388
Brief Title
Different Endoscopic Gastric Cancer Risk Assessments
Official Title
Different Endoscopic Gastric Cancer Risk Assessments for the Detection of Early Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 4, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yanqing Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer Screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
3500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kimura-Takemoto classification
Arm Type
Active Comparator
Arm Title
EGGIM
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Kimura-Takemoto classification
Intervention Description
All patients were given two risk scores, the order of which was randomly determined.
Intervention Type
Procedure
Intervention Name(s)
EGGIM
Intervention Description
All patients were given two risk scores, the order of which was randomly determined.
Primary Outcome Measure Information:
Title
Early gastric cancer detection rate
Description
The detection rate of early gastric cancer
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 40-80 years undergoing gastroscopy
Patients intend to undergo ESD treatment
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan-qing Li
Phone
+8653188369277
Email
liyanqing@sdu.edu.cn
Facility Information:
Facility Name
Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, PhD,MD
Phone
053182169385
Email
liyanqing@sdu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Different Endoscopic Gastric Cancer Risk Assessments
We'll reach out to this number within 24 hrs