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RecruitingNCT05458388Updated Jul 14, 2022

Different Endoscopic Gastric Cancer Risk Assessments

An interventional study of Kimura-Takemoto classification and EGGIM in Gastric Cancer Screening, sponsored by Yanqing Li. Recruiting at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-14.

Sponsored by Yanqing Li · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
3,500
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Cancer Screening

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03

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients aged 40-80 years undergoing gastroscopy
  • Patients intend to undergo ESD treatment

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
3,500 participants (estimated)

Study arms

  • Active comparator
    Kimura-Takemoto classification

    Procedure: Kimura-Takemoto classification

  • Active comparator
    EGGIM

    Procedure: EGGIM

Interventions

  • ProcedureKimura-Takemoto classification

    All patients were given two risk scores, the order of which was randomly determined.

  • ProcedureEGGIM

    All patients were given two risk scores, the order of which was randomly determined.

05

What researchers measure

Primary outcomes

  1. Early gastric cancer detection rate

    The detection rate of early gastric cancer

    Time frame: 36 months

06

Study locations

1 of 1 sites recruiting
  • Qilu Hospital, Shandong University
    Jinan, Shandong 250001, China
    Recruiting
07

Registry details

Key details

Study ID
NCT05458388
Lead sponsor
Yanqing Li
Responsible party
Yanqing Li (Vice President of Qilu Hospital, Shandong University) — Sponsor-investigator
First posted
Jul 14, 2022
Start date
Jul 12, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Jul 4, 2025 (estimated)
Last update
Jul 14, 2022

Study contacts

Yan-qing Li
Contact
liyanqing@sdu.edu.cn
+8653188369277

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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