ClinicalTrials.gg
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

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jul 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
3,500
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,180 studies in Stomach Neoplasms with a site in China — 479 open to participants now, 553 under way, 50 of them phase 3. Stomach Neoplasms · China.

Planned enrollment
5th of 878
3,500 · median 88
Started
2022
with 103 others
No phase
221 of 1,180
95 open now
Primary completion
2024-12
later than 92 of 552 live
Registered
629th of 1,180
by date

Among the 1,180 studies in Stomach Neoplasms with a site in China, this one is the 5th largest by planned enrollment of the 878 interventional ones that give a count, is one of 104 that started in 2022, is one of 221 with no phase, reaches primary completion later than 92 of the 552 other live ones, and was the 629th registered.

Stomach Neoplasms

3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.

Browse Stomach Neoplasms studies →

Open to participants now

479 of the 1,180 studies in Stomach Neoplasms with a site in China are open now. Recruiting first, the newest first:

474 more — sign in →

All 479 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 702 Stomach Neoplasms studies recruiting now, 375 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 68 take healthy volunteers.

This study: 40 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,180 studies in Stomach Neoplasms with a site in China, or all of them as a file.
02

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.

03

Conditions studied

  • Gastric Cancer Screening

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04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to
  • Patients who refuse to sign the form.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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.

06

What researchers measure

Primary outcomes

  1. Early gastric cancer detection rate

    The detection rate of early gastric cancer

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2022 (actual). Primary completion is estimated for Dec 2024, 29 months after the start.

Of 356 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's planned 29 months is below that.

Counting every sponsor, half of 367 studies reached it within 36 months; a quarter within 17 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2022
First posted
Jul 14, 2022
StartActual
Jul 12, 2022
Primary completionEst.
Dec 31, 2024
CompletionEst.
Jul 4, 2025
Last update
Jul 14, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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