Gastric CancerNCT04184960
AG & IM in CA Stomach Protocol
An observational study of Gastric Cancer and Atrophic Gastritis, run by Chinese University of Hong Kong at 4 sites in 4 countries.
Trial summary
This is a multi-center prospective case control study aiming to compare different methods of risk stratification models in predicting the risk of gastric cancer development. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Atrophic Gastritis, Intestinal Metaplasia
- What is being tested?
- Gastroscopy and gastric biopsies
- How many people
- 400 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 5 Dec 2019to 31 Mar 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with or without gastric cancer undergoing elective endoscopy would be recruited if they fulfil inclusion and exclusion criteria. Subsequently they would be analysed based on "Gastric cancer" and "Non-gastric cancer" cohorts.
Who may be able to join
- Age 40 or above
- Undergo elective upper gastrointestinal endoscopy
Who cannot join
- Patients with history of gastrectomy
- Patients with severe thrombocytopenia (Platelet count <50) or coagulopathy (INR > 1.5 or on anticoagulation)
- Contraindication to upper gastrointestinal endoscopy
- Allergy towards sedative agents (Midazolam / Diazepam) or local anaesthetic spray (Lignocaine)
- Patients who cannot give informed consent
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Hon Chi Yip, FRCSEd (Gen), +852 35052627, hcyip@surgery.cuhk.edu.hk
Japan1 site, 1 recruiting
- Not yet recruiting
Osaka International Cancer Institute
Osaka
Noriya Uedo, noriya.uedo@gmail.com
Singapore1 site, 1 recruiting
- Not yet recruiting
Changi General Hospital
Singapore
James Weiquan Li, james.li.w.q@singhealth.com.sg
Thailand1 site, 1 recruiting
- Not yet recruiting
King Chulalongkorn Memorial Hospital and Chulalongkorn University
Bangkok
Rapat Pittayanon, MD, MSc, rapat125@gmail.com
About this study
Official title: Performance of Endoscopic and Histological Criteria of Atrophic Gastritis and Intestinal Metaplasia in Predicting Risk of Gastric Cancer - a Multicenter Case Control Study
This is a multi-center prospective case control study aiming to compare different methods of risk stratification models in predicting the risk of gastric cancer development.
Read the detailed description
The case control study would compare which type of assessment (Endoscopic / histological) is more accurate in predicting the risk of gastric cancer development.
The risk factor assessment would be based on the following criteria.
Endoscopic assessment:
- Atrophic gastritis, based on Kimura Takemoto Classification
- Kyoto classification of gastritis
- Intestinal metaplasia, based on Endoscopic Mapping and Grading of Intestinal Metaplasia (EGGIM) Histological assessment (Based on random biopsies)
- Operative Links on Gastritis Assessment 2. Operative Links on Gastric Intestinal Metaplasia
- Conditions
- Gastric Cancer, Atrophic Gastritis, Intestinal Metaplasia
- Being tested
- Gastroscopy and gastric biopsies
- Keywords
- Gastric cancer, Gastroscopy, Atrophic gastritis, Intestinal metaplasia
- Medical subject headings
- Stomach Neoplasms, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastroscopy and gastric biopsiesDiagnostic test
Gastroscopy would be performed to assess the degree of atrophic gastritis and intestinal metaplasia. In addition, four random biopsies would be taken in the stomach for histological assessment of AG and IM
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer cohort | Cohort of patients with gastric cancer Receives: Diagnostic Test: Gastroscopy and gastric biopsies | |
| Non-gastric cancer cohort | Cohort of patients without gastric cancer Receives: Diagnostic Test: Gastroscopy and gastric biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic grading of atrophic gastritis (Kimura Takemoto Classification)
Endoscopic description of severity of gastric atrophy
Measured: Cross sectional study, day 0
Endoscopic grading of intestinal metaplasia (EGGIM)
Endoscopic mapping of degree of intestinal metaplasia
Measured: Cross sectional study, day 0
Kyoto classification of gastritis
Descriptive findings of gastritis
Measured: Cross sectional study, day 0
Operative links on gastritis assessment (OLGA)
Biopsy based risk stratification panel based on severity of atrophic gastritis
Measured: Cross sectional study, day 0
Operative links on gastric intestinal metaplasia (OLGIM)
Biopsy based risk stratification panel based on severity of intestinal metaplasia
Measured: Cross sectional study, day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start5 Dec 2019
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hon Chi Yip, Chinese University of Hong Kong
- Investigators
- Hon Chi Yip, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184960
- Sponsor's protocol ID
- CRE-2019.341
- Status last verified
- Sep 2023
- First submitted
- 1 Dec 2019
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Endoscopic and Histological Criteria of Atrophic Gastritis and Intestinal Metaplasia in Predicting Risk of Gastric Cancer - a Multicenter Case Control Study
- ClinicalTrials.gov ID
- NCT04184960
- Acronym / sponsor ID
- CRE-2019.341
- Conditions
- Gastric Cancer, Atrophic Gastritis, Intestinal Metaplasia
- Keywords
- Gastric cancer, Gastroscopy, Atrophic gastritis, Intestinal metaplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 4 Dec 2019 (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.
This is a multi-center prospective case control study aiming to compare different methods of risk stratification models in predicting the risk of gastric cancer development.
Detailed description
The case control study would compare which type of assessment (Endoscopic / histological) is more accurate in predicting the risk of gastric cancer development.
The risk factor assessment would be based on the following criteria.
Endoscopic assessment:
- Atrophic gastritis, based on Kimura Takemoto Classification
- Kyoto classification of gastritis
- Intestinal metaplasia, based on Endoscopic Mapping and Grading of Intestinal Metaplasia (EGGIM) Histological assessment (Based on random biopsies)
- Operative Links on Gastritis Assessment 2. Operative Links on Gastric Intestinal Metaplasia
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer cohort | – | Diagnostic Test: Gastroscopy and gastric biopsiesCohort of patients with gastric cancer |
| Non-gastric cancer cohort | – | Diagnostic Test: Gastroscopy and gastric biopsiesCohort of patients without gastric cancer |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with or without gastric cancer undergoing elective endoscopy would be recruited if they fulfil inclusion and exclusion criteria. Subsequently they would be analysed based on "Gastric cancer" and "Non-gastric cancer" cohorts.
Key inclusion criteria (2 listed)
- Age 40 or above
- Undergo elective upper gastrointestinal endoscopy
Key exclusion criteria (5 listed)
- Patients with history of gastrectomy
- Patients with severe thrombocytopenia (Platelet count <50) or coagulopathy (INR > 1.5 or on anticoagulation)
- Contraindication to upper gastrointestinal endoscopy
- Allergy towards sedative agents (Midazolam / Diazepam) or local anaesthetic spray (Lignocaine)
- Patients who cannot give informed consent
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 |
|---|---|---|
| Gastroscopy and gastric biopsiesGastroscopy would be performed to assess the degree of atrophic gastritis and intestinal metaplasia. In addition, four random biopsies would be taken in the stomach for histological assessment of AG and IM | Diagnostic test | Gastric cancer cohort, Non-gastric cancer cohort |
Primary outcome
Endoscopic grading of atrophic gastritis (Kimura Takemoto Classification)
Time frame: Cross sectional study, day 0
Endoscopic description of severity of gastric atrophy
Endoscopic grading of intestinal metaplasia (EGGIM)
Time frame: Cross sectional study, day 0
Endoscopic mapping of degree of intestinal metaplasia
Kyoto classification of gastritis
Time frame: Cross sectional study, day 0
Descriptive findings of gastritis
Operative links on gastritis assessment (OLGA)
Time frame: Cross sectional study, day 0
Biopsy based risk stratification panel based on severity of atrophic gastritis
Operative links on gastric intestinal metaplasia (OLGIM)
Time frame: Cross sectional study, day 0
Biopsy based risk stratification panel based on severity of intestinal metaplasia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Hon Chi Yip principal investigator
Chinese University of Hong Kong
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Atrophic Gastritis, run by Chinese University of Hong Kong at 4 sites in 4 countries.
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 5 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hong Kong, Japan, Singapore, Thailand. 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 Hon Chi Yip, FRCSEd(Gen) (+852 35052627, hcyip@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic grading of atrophic gastritis (Kimura Takemoto Classification) (time frame: Cross sectional study, day 0). The study lists 5 primary outcomes in all. 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 7 Sep 2023.