Early Gastric CancerNCT02562976
OLGA Stage is More Appropriate in Predicting Early Gastric Cancer
An observational study of Early Gastric Cancer, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
The aim of the present study was to evaluate characteristics of background mucosa in early gastric cancer (EGC), and to seek for the optimal assessment for EGC screening. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- gastric atrophy and intestinal metaplasia
- How many people
- 227 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jul 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study involved consecutive patients from 40-80 years who undergoing esophagogastroduodenoscopy
Who may be able to join
- The age of patients is from 40-80 years
- Must undergo esophagogastroduodenoscopy
Who cannot join
- Clinical diagnosis of advanced gastric cancer
- Post-subtotal gastrectomy
- Acute upper gastrointestinal bleeding
- Severe systemic diseases
- Lack histology
About this study
Official title: OLGA Stage is More Appropriate in Predicting Early Gastric Cancer Than Endoscopic Gastric Atrophy Classification and OLGIM Stage: A Prospective Study
The aim of the present study was to evaluate characteristics of background mucosa in early gastric cancer (EGC), and to seek for the optimal assessment for EGC screening.
Read the detailed description
Japanese endoscopic gastric atrophy (EGA) classification, operative link on Gastritis Assessment (OLGA), operative link on intestinal metaplasia assessment (OLGIM) and gastritis pattern are used in evaluating the severity of gastritis and intestinal metaplasia in different countries, which are risk factors of gastric cancer. The aim of the present study was to evaluate characteristics of background mucosa in early gastric cancer (EGC), and to seek for the optimal assessment for EGC screening.
A prospective study was conducted encompassing EGC patients (cases) and non-EGC patients (controls). All patients were performed endoscopic examination and systematically biopsied. Outcome measures were assessed and compared, including EGA classification as well as the OLGA/OLGIM assessment. Helicobacter pylori(H. pylori) status was detected in the meantime. A stepwise logistic regression model was performed to analyze correlations between EGA, OLGA, OLGIM and EGC.
- Conditions
- Early Gastric Cancer
- Being tested
- gastric atrophy and intestinal metaplasia
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric atrophy and intestinal metaplasiaOther
use Japanese endoscopic gastric atrophy classification, Operative Link on Gastritis Assessment (OLGA), Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) to evaluate the severity of gastric atrophy and intestinal metaplasia
| Study group | Role | What they receive |
|---|---|---|
| early gastric cancer group | use Japanese endoscopic gastric atrophy classification, Operative Link on Gastritis Assessment (OLGA), Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) to evaluate the severity of gastric atrophy and intestinal metaplasia in patients with early gastric cancer or high-grade neoplasia(HGN) Receives: Other: gastric atrophy and intestinal metaplasia | |
| non-early gastric cancer group | patients diagnosed as non- gastritis, gastritis or low-grade neoplasia (LGN) by pathology were defined as non-EGC group Receives: Other: gastric atrophy and intestinal metaplasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with severe gastric atrophy and/or intestinal metaplasia in early gastric cancer and non-early gastric cancer
use the Japanese endoscopic gastric atrophy (EGA) classification(it has 6 stages-C1,C2,C3,O1,O2,O3), Operative Link on Gastritis Assessment (OLGA,it has 4 stages-I,II,III,IV), and Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM,it has 4 stages-I,II,III,IV) to pick out severe gastric atrophy and/or intestinal metaplasia(EGA stage C3-O3,OLGA/OLGIM stage III-IV)
Measured: up to 27 months
Secondary outcomes (2)
correlations between Japanese endoscopic gastric atrophy (EGA) classification, Operative Link on Gastritis Assessment (OLGA), Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) and early gastric cancer
Measured: up to 27 months
correlations between Helicobacter pylori infection and moderate-to-severe EGA classification, OLGA stage III-IV, OLGIM stage III-IV
EGA means endoscopic gastric atrophy classification,OLGA means Operative Link on Gastritis Assessment, and OLGIM means Operative Link on Gastric Intestinal Metaplasia Assessment
Measured: up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startMay 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobo Li, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xiaobo Li, MD.Ph.D, Principal investigator, Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562976
- Sponsor's protocol ID
- rjxhnk3062
- Status last verified
- Sep 2015
- First submitted
- 22 Sep 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OLGA Stage is More Appropriate in Predicting Early Gastric Cancer Than Endoscopic Gastric Atrophy Classification and OLGIM Stage: A Prospective Study
- ClinicalTrials.gov ID
- NCT02562976
- Acronym / sponsor ID
- rjxhnk3062
- Conditions
- Early Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Sep 2015 (estimated)
- 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 aim of the present study was to evaluate characteristics of background mucosa in early gastric cancer (EGC), and to seek for the optimal assessment for EGC screening.
Detailed description
Japanese endoscopic gastric atrophy (EGA) classification, operative link on Gastritis Assessment (OLGA), operative link on intestinal metaplasia assessment (OLGIM) and gastritis pattern are used in evaluating the severity of gastritis and intestinal metaplasia in different countries, which are risk factors of gastric cancer. The aim of the present study was to evaluate characteristics of background mucosa in early gastric cancer (EGC), and to seek for the optimal assessment for EGC screening.
A prospective study was conducted encompassing EGC patients (cases) and non-EGC patients (controls). All patients were performed endoscopic examination and systematically biopsied. Outcome measures were assessed and compared, including EGA classification as well as the OLGA/OLGIM assessment. Helicobacter pylori(H. pylori) status was detected in the meantime. A stepwise logistic regression model was performed to analyze correlations between EGA, OLGA, OLGIM and EGC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early gastric cancer group | – | Other: gastric atrophy and intestinal metaplasiause Japanese endoscopic gastric atrophy classification, Operative Link on Gastritis Assessment (OLGA), Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) to evaluate the severity of gastric atrophy and intestinal metaplasia in patients with early gastric cancer or high-grade neoplasia(HGN) |
| non-early gastric cancer group | – | Other: gastric atrophy and intestinal metaplasiapatients diagnosed as non- gastritis, gastritis or low-grade neoplasia (LGN) by pathology were defined as non-EGC group |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study involved consecutive patients from 40-80 years who undergoing esophagogastroduodenoscopy
Key inclusion criteria (2 listed)
- The age of patients is from 40-80 years
- Must undergo esophagogastroduodenoscopy
Key exclusion criteria (5 listed)
- Clinical diagnosis of advanced gastric cancer
- Post-subtotal gastrectomy
- Acute upper gastrointestinal bleeding
- Severe systemic diseases
- Lack histology
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 |
|---|---|---|
| gastric atrophy and intestinal metaplasiause Japanese endoscopic gastric atrophy classification, Operative Link on Gastritis Assessment (OLGA), Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) to evaluate the severity of gastric atrophy and intestinal metaplasia | Other | early gastric cancer group, non-early gastric cancer group |
Primary outcome
Number of patients with severe gastric atrophy and/or intestinal metaplasia in early gastric cancer and non-early gastric cancer
Time frame: up to 27 months
use the Japanese endoscopic gastric atrophy (EGA) classification(it has 6 stages-C1,C2,C3,O1,O2,O3), Operative Link on Gastritis Assessment (OLGA,it has 4 stages-I,II,III,IV), and Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM,it has 4 stages-I,II,III,IV) to pick out severe gastric atrophy and/or intestinal metaplasia(EGA stage C3-O3,OLGA/OLGIM stage III-IV)
2 secondary outcomes
correlations between Japanese endoscopic gastric atrophy (EGA) classification, Operative Link on Gastritis Assessment (OLGA), Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) and early gastric cancer
Time frame: up to 27 months
correlations between Helicobacter pylori infection and moderate-to-severe EGA classification, OLGA stage III-IV, OLGIM stage III-IV
Time frame: up to 27 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
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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.
Xiaobo Li, MD.Ph.D principal investigator
Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai
Questions about this trial
What is this clinical trial studying?
An observational study of Early Gastric Cancer, run by Shanghai Jiao Tong University School of Medicine.
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: finished, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with severe gastric atrophy and/or intestinal metaplasia in early gastric cancer and non-early gastric cancer (time frame: up to 27 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 29 Sep 2015.