OLGA Stage is More Appropriate in Predicting Early Gastric Cancer

September 27, 2015 updated by: Xiaobo Li, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
227

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study involved consecutive patients from 40-80 years who undergoing esophagogastroduodenoscopy

Description

Inclusion Criteria:

  • The age of patients is from 40-80 years
  • Must undergo esophagogastroduodenoscopy

Exclusion Criteria:

  • Clinical diagnosis of advanced gastric cancer
  • Post-subtotal gastrectomy
  • Acute upper gastrointestinal bleeding
  • Severe systemic diseases
  • Lack histology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Other: gastric atrophy and intestinal metaplasia
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
non-early gastric cancer group
patients diagnosed as non- gastritis, gastritis or low-grade neoplasia (LGN) by pathology were defined as non-EGC group
Other: gastric atrophy and intestinal metaplasia
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
up to 27 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
EGA means endoscopic gastric atrophy classification,OLGA means Operative Link on Gastritis Assessment, and OLGIM means Operative Link on Gastric Intestinal Metaplasia Assessment
up to 27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Jiao Tong University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaobo Li, MD.Ph.D, Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • rjxhnk3062

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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