Atrophic GastritisNCT06203327
Atrophic Gastritis Predicts the Risk of Gastric Cancer
An observational study of Atrophic Gastritis, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Despite declining incidence rates, gastric cancer (GC) ranks the fourth leading cause of cancer-related mortality and the fifth most common cancer worldwide, with the highest incidence reported in Eastern Asia. The 5-year overall survival rate of early GC exceeds 90%, which was well above advanced GC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrophic Gastritis
- What is being tested?
- Esophagogastroscopy (OLGA 0-Ⅰ), Esophagogastroscopy (OLGA II) and Esophagogastroscopy (OLGA III-IV)
- Type of treatment
- Injection or infusion
- How many people
- 2,042 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2023to 31 Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic gastritis diagnosed by routine endoscopic screening
Who may be able to join
- Ability and willingness to participate in the study and to sign and give informed consent
- Biopsies were collected based on the recommendation of updated Sydney system
Who cannot join
- under 18 or over 80 years old
- history of gastrectomy
- severe systemic diseases or malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Yu Huang, M.M., 86+18621791879, 15626211482@163.com
Hong Lu, M.D.,Ph.D
About this study
Official title: Atrophic Gastritis Predicts the Risk of Gastric Cancer: a Prospective Cohort Study
Despite declining incidence rates, gastric cancer (GC) ranks the fourth leading cause of cancer-related mortality and the fifth most common cancer worldwide, with the highest incidence reported in Eastern Asia. The 5-year overall survival rate of early GC exceeds 90%, which was well above advanced GC. Most intestinal-type GCs follow the Correa cascade-inflammation,atrophy, intestinal metaplasia (IM), dysplasia and subsequent carcinoma. The presence of gastric mucosal atrophy and intestinal metaplasia are important risk factors for GC. The purpose of this study was to investigate the incidence of GC attributed to atrophic gastritis in a region with high incidence of GC.
- Conditions
- Atrophic Gastritis
- Being tested
- Esophagogastroscopy (OLGA 0-Ⅰ), Esophagogastroscopy (OLGA II), Esophagogastroscopy (OLGA III-IV)
- Keywords
- Atrophic Gastritis, Gastric Cancer
- Medical subject headings
- Gastritis, Atrophic, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophagogastroscopy (OLGA 0-Ⅰ)Other
Surveillance endoscopies at years 3-5.
Esophagogastroscopy (OLGA II)Other
Surveillance endoscopies at years 2-3.
Esophagogastroscopy (OLGA III-IV)Other
Surveillance endoscopies every year.
| Study group | Role | What they receive |
|---|---|---|
| OLGA 0-I | Not described Receives: Other: Esophagogastroscopy (OLGA 0-Ⅰ) | |
| OLGA II | Not described Receives: Other: Esophagogastroscopy (OLGA II) | |
| OLGA III-IV | Not described Receives: Other: Esophagogastroscopy (OLGA III-IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
early gastric neoplasm
histological diagnosis of high-grade dysplasia, and adenocarcinoma.
Measured: After the baseline endoscopy, participants were scheduled for surveillance endoscopies at years 3-5 for subjects with operative link on gastritis assessment (OLGA) 0-Ⅰ, at years 2-3 for subjects with OLGA II and 1 year for subjects with OLGA III-IV.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start15 Dec 2023
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic GastritisStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,042 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Lu, MD, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203327
- Sponsor's protocol ID
- rjhy20230004
- Status last verified
- Dec 2023
- First submitted
- 25 Dec 2023
- Last updated
- 30 Dec 2024
- 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 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrophic Gastritis Predicts the Risk of Gastric Cancer: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06203327
- Acronym / sponsor ID
- rjhy20230004
- Conditions
- Atrophic Gastritis
- Keywords
- Atrophic Gastritis, Gastric Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,042 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 12 Jan 2024 (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.
Despite declining incidence rates, gastric cancer (GC) ranks the fourth leading cause of cancer-related mortality and the fifth most common cancer worldwide, with the highest incidence reported in Eastern Asia. The 5-year overall survival rate of early GC exceeds 90%, which was well above advanced GC. Most intestinal-type GCs follow the Correa cascade-inflammation,atrophy, intestinal metaplasia (IM), dysplasia and subsequent carcinoma. The presence of gastric mucosal atrophy and intestinal metaplasia are important risk factors for GC. The purpose of this study was to investigate the incidence of GC attributed to atrophic gastritis in a region with high incidence of GC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OLGA 0-I | – | Other: Esophagogastroscopy (OLGA 0-Ⅰ) |
| OLGA II | – | Other: Esophagogastroscopy (OLGA II) |
| OLGA III-IV | – | Other: Esophagogastroscopy (OLGA III-IV) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic gastritis diagnosed by routine endoscopic screening
Key inclusion criteria (2 listed)
- Ability and willingness to participate in the study and to sign and give informed consent
- Biopsies were collected based on the recommendation of updated Sydney system
Key exclusion criteria (3 listed)
- under 18 or over 80 years old
- history of gastrectomy
- severe systemic diseases or malignancy
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 |
|---|---|---|
| Esophagogastroscopy (OLGA 0-Ⅰ)Surveillance endoscopies at years 3-5. | Other | OLGA 0-I |
| Esophagogastroscopy (OLGA II)Surveillance endoscopies at years 2-3. | Other | OLGA II |
| Esophagogastroscopy (OLGA III-IV)Surveillance endoscopies every year. | Other | OLGA III-IV |
Primary outcome
early gastric neoplasm
Time frame: After the baseline endoscopy, participants were scheduled for surveillance endoscopies at years 3-5 for subjects with operative link on gastritis assessment (OLGA) 0-Ⅰ, at years 2-3 for subjects with OLGA II and 1 year for subjects with OLGA III-IV.
histological diagnosis of high-grade dysplasia, and adenocarcinoma.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- 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.
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrophic Gastritis, run by Shanghai Jiao Tong University School of Medicine 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 3 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: looking for participants now, as of the sponsor's last update on 30 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early gastric neoplasm (time frame: After the baseline endoscopy, participants were scheduled for surveillance endoscopies at years 3-5 for subjects with operative link on gastritis assessment (OLGA) 0-Ⅰ, at years 2-3 for subjects with OLGA II and 1 year for subjects with OLGA III-IV.). 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 30 Dec 2024.