Different Endoscopic Gastric Cancer Risk Assessments

NCT ID: NCT05458388

Last Updated: 2022-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

3500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-12

Study Completion Date

2025-07-04

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Kimura-Takemoto classification

Group Type ACTIVE_COMPARATOR

Kimura-Takemoto classification

Intervention Type PROCEDURE

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

EGGIM

Group Type ACTIVE_COMPARATOR

EGGIM

Intervention Type PROCEDURE

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

Interventions

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Kimura-Takemoto classification

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

Intervention Type PROCEDURE

EGGIM

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yanqing Li

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice President of Qilu Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan-qing Li

Role: CONTACT

+8653188369277

Facility Contacts

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Yanqing Li, PhD,MD

Role: primary

053182169385

Other Identifiers

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2022-SDU-QILU-120

Identifier Type: -

Identifier Source: org_study_id

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