NCT05459428

Brief Summary

Current national guidelines recommend the use of OLGIM score to evaluate the risk of gastric cancer in patients, and close gastroscopic monitoring should be performed after OLGIM grade III/IV. However, it would not be clinically feasible to require at least four biopsies. Confocal laser endomicroscopy is able to magnify the tissue by 1000X, which can be seen at the cellular level. Observing goblet cells under Confocal laser endomicroscopy is simpler and diagnostic accuracy is comparable to pathology. Confocal laser endomicroscopy enables better assessment of intestinal metaplasia in gastric mucosa, thus quantifying the risk of gastric cancer and avoiding multiple biopsies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

2.1 years

First QC Date

July 8, 2022

Last Update Submit

July 12, 2022

Conditions

Intestinal Metaplasia of Gastric MucosaConfocal Laser Endomicroscopy

Outcome Measures

Primary Outcomes (6)

  • Endoscopists concluded the sensitivity of CGGIM score in the diagnosis of OLGIM III/IV

    The confocal grading of gastric intestinal metaplasia (CGGIM) may be used to assess a patient's risk by the endoscopic assessment of IM in the antrum, incisura, and corpus with the use of confocal laser endomicroscopy. The minimum score is 0 and the maximum score is 10. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients. CGGIM scores were calculated to be compared with OLGIM based on the results of the endoscopist 's procedure.

    2 years

  • Endoscopists derive the specificity of CGGIM score in the diagnosis of OLGIM III/IV

    The confocal grading of gastric intestinal metaplasia (CGGIM) may be used to assess a patient's risk by the endoscopic assessment of IM in the antrum, incisura, and corpus with the use of confocal laser endomicroscopy. The minimum score is 0 and the maximum score is 10. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients. CGGIM scores were calculated to be compared with OLGIM based on the results of the endoscopist 's procedure.

    2 years

  • Accuracy of CGGIM Score for Diagnosing OLGIM III/IV by Endoscopists

    The confocal grading of gastric intestinal metaplasia (CGGIM) may be used to assess a patient's risk by the endoscopic assessment of IM in the antrum, incisura, and corpus with the use of confocal laser endomicroscopy. The minimum score is 0 and the maximum score is 10. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients. CGGIM scores were calculated to be compared with OLGIM based on the results of the endoscopist 's procedure.

    2 years

  • AI yielded the sensitivity of CGGIM score in the diagnosis of OLGIM III/IV

    The confocal grading of gastric intestinal metaplasia (CGGIM) may be used to assess a patient's risk by the endoscopic assessment of IM in the antrum, incisura, and corpus with the use of confocal laser endomicroscopy. The minimum score is 0 and the maximum score is 10. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients. CGGIM scores were calculated based on existing AI model identification results and compared with OLGIM.

    2 years

  • AI yielded the specificity of CGGIM score in the diagnosis of OLGIM III/IV

    The confocal grading of gastric intestinal metaplasia (CGGIM) may be used to assess a patient's risk by the endoscopic assessment of IM in the antrum, incisura, and corpus with the use of confocal laser endomicroscopy. The minimum score is 0 and the maximum score is 10. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients. CGGIM scores were calculated based on existing AI model identification results and compared with OLGIM.

    2 years

  • AI yields accuracy of CGGIM score for diagnosis of OLGIM III/IV

    The confocal grading of gastric intestinal metaplasia (CGGIM) may be used to assess a patient's risk by the endoscopic assessment of IM in the antrum, incisura, and corpus with the use of confocal laser endomicroscopy. The minimum score is 0 and the maximum score is 10. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients. CGGIM scores were calculated based on existing AI model identification results and compared with OLGIM.

    2 years

Secondary Outcomes (1)

  • Comparison of accuracy of CGGIM score between AI and endoscopists in diagnosing OLGIM III/IV

    2 years

Study Arms (2)

Confocal laser endomicroscopy scoring of the extent of intestinal metaplasia

Get pictures and Videos from gastric antrum body and angle by confocal laser endomicroscopy in order to calculate the CGGIM score.

Artificial intelligence scoring of the extent of intestinal metaplasia

Get pictures and Videos from gastric antrum body and angle by Artificial intelligence in order to calculate the CGGIM score.

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People at high risk of developing stomach cancer

You may qualify if:

  • Patients aged 40-80 years undergoing the confocal laser endomicroscopy examination

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

Study Sites (1)

Department of Gastroenterology, QiLu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

When a gastric mucosal lesion is found using confocal laser microendoscopy, endoscopist will take biopsy for histology examination. In addition, random biopsies to ensure at least four biopsies from the gastric antrum and body to cauculate the OLGIM

Study Officials

  • Yanqing Li, MD, PhD

    Qilu Hospital of Shandong University

    STUDY CHAIR

Central Study Contacts

Yanqing Li, MD, PhD

CONTACT

0531182169385liyanqing@sdu.edu.cn

Rui Ji, MD, PhD

CONTACT

18560086103qljirui@email.sdu.edu.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of Qilu Hospital

Study Record Dates

First Submitted

July 8, 2022

First Posted

July 15, 2022

Study Start

May 20, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

July 15, 2022

Record last verified: 2022-07

Locations

CN(1)