Gastric Cancer ScreeningNCT05458388
Different Endoscopic Gastric Cancer Risk Assessments
A study testing Kimura-Takemoto classification and EGGIM in people with Gastric Cancer Screening, run by Yanqing Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Gastric Cancer Screening
- What is being tested?
- Kimura-Takemoto classification and EGGIM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2022to 4 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40-80 years undergoing gastroscopy
- Patients intend to undergo ESD treatment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital, Shandong University
Jinan, Shandong, 250001
Yanqing Li, PhD,MD, 053182169385, liyanqing@sdu.edu.cn
About this study
Official title: Different Endoscopic Gastric Cancer Risk Assessments for the Detection of Early Gastric Cancer
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.
- Conditions
- Gastric Cancer Screening
- Being tested
- Kimura-Takemoto classification, EGGIM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kimura-Takemoto classificationProcedure or surgery
All patients were given two risk scores, the order of which was randomly determined.
EGGIMProcedure or surgery
All patients were given two risk scores, the order of which was randomly determined.
| Study group | Role | What they receive |
|---|---|---|
| Kimura-Takemoto classification | Active comparator | Not described Receives: Procedure: Kimura-Takemoto classification |
| EGGIM | Active comparator | Not described Receives: Procedure: EGGIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early gastric cancer detection rate
The detection rate of early gastric cancer
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start12 Jul 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion4 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanqing Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458388
- Sponsor's protocol ID
- 2022-SDU-QILU-120
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Endoscopic Gastric Cancer Risk Assessments for the Detection of Early Gastric Cancer
- ClinicalTrials.gov ID
- NCT05458388
- Acronym / sponsor ID
- 2022-SDU-QILU-120
- Conditions
- Gastric Cancer Screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Yanqing LiUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 4 Jul 2025 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kimura-Takemoto classification | Active comparator | Procedure: Kimura-Takemoto classification |
| EGGIM | Active comparator | Procedure: EGGIM |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 40-80 years undergoing gastroscopy
- Patients intend to undergo ESD treatment
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kimura-Takemoto classificationAll patients were given two risk scores, the order of which was randomly determined. | Procedure or surgery | Kimura-Takemoto classification |
| EGGIMAll patients were given two risk scores, the order of which was randomly determined. | Procedure or surgery | EGGIM |
Primary outcome
Early gastric cancer detection rate
Time frame: 36 months
The detection rate of early gastric cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kimura-Takemoto classification and EGGIM in people with Gastric Cancer Screening, run by Yanqing Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan-qing Li (+8653188369277, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early gastric cancer detection rate (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.