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CompletedNCT03380052Updated Apr 13, 2023

OLGA and OLGIM Stage System for Gastric Cancer

An observational study in Stomach Neoplasms, Atrophic Gastritis and Intestinal Metaplasia, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 25 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-13.

Sponsored by Seoul National University Bundang Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,900
Ages
25 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 25 studies in Stomach Neoplasms by Seoul National University Bundang Hospital — none open to participants now, 3 under way, none of them phase 3. Stomach Neoplasms · Seoul National University Bundang Hospital.

Enrollment
4th of 10
2,900 · median 288
Started
2006
the only one that year
Observational
10 of 25
none open now
Registered
13th of 25
by date

Among the 25 studies in Stomach Neoplasms by Seoul National University Bundang Hospital, this one is the 4th largest by enrollment of the 10 observational ones that give a count, is the only one that started in 2006, is one of 10 observational ones, and was the 13th registered.

Stomach Neoplasms

3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.

Browse Stomach Neoplasms studies →

Open to participants now

None of the 25 studies in Stomach Neoplasms by Seoul National University Bundang Hospital is open now. The open studies under Stomach Neoplasms, anywhere →

Where they have run

Who these studies take

Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.

This study: 25 Years to 80 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 25 studies in Stomach Neoplasms by Seoul National University Bundang Hospital as a file.
02

Study summary

To validate OLGA and OLGIM staging system with serum pepsinogen for estimating GC risk according to Lauren's histologic classification in South Korea. Also attempted to estimate synergistic interaction among the several risk factors to help establish surveillance strategy.

Read the detailed description

To validated the OLGA and OLGIM staging system with serum pepsinogen to estimate gastric cancer risk according to Lauren's histologic classification in South Korea, where the incidence rate of GC is high. In addition, the investigators attempted to investigate the interaction among the several risk factors including OLGA or OLGIM staging system for the risk of GC to help establish surveillance strategy.

03

Conditions studied

  • Stomach Neoplasms
  • Atrophic Gastritis
  • Intestinal Metaplasia

Keywords

  • OLGA
  • OLGIM
  • Helicobacter pylori
  • Gastric cancer
  • pepsinogen
04

Who can participate

Ages eligible
25 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients who visited gastroenterology department complaining of gastrointestinal symptoms and underwent esophagogastroduodenoscopy (EGD)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Control group

    • those who were between 25 and 80 years old and did not have any evidence of gastric cancer and gastric dysplasia, esophageal tumor and MALToma in upper gastrointestinal endoscopy
  • Gastric cancer group

    • Patients diagnosed as gastric cancer in the upper gastrointestinal endoscopy at the time of participating in the study between 25 and 80 years old.

Exclusion criteria

Exclusion Criteria:

  • history of previous gastrointestinal surgery,
  • any other
  • cardia cancer
  • who do not perform endoscopic
  • proven gastric dysplasia
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,900 participants (actual)
Patient registry
No

Groups and cohorts

  • Gastric cancer

    Patients who were diagnosed with gastric cancer

  • Control

    Healthy participants or benign disease patients such as benign gastric ulcers, duodenal ulcers, reflux esophagitis, or non-erosive reflux disease

06

What researchers measure

Primary outcomes

  1. The evaluation of OLGA and OLGIM stage systems with serum pepsinogen for prediction of gastric cancer risk

    To validate OLGA and OLGIM staging system with serum pepsinogen for estimating GC risk according to Lauren's histologic classification

    Time frame: per 1 year

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 463-707, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2006 to primary completion in Jan 2021, 179 months.

Of 323 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 171. This study's 179 months is above that.

Counting every sponsor, half of 365 studies reached it within 54 months; a quarter within 29 and three quarters within 119.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2017
First posted
Dec 20, 2017
StartActual
Feb 2006
Primary completionActual
Jan 2021
CompletionActual
Jan 2022
Last update
Apr 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03380052
Collaborators
National Clinical Research Coordination Center, Seoul, Korea
Responsible party
Nayoung Kim (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Dec 20, 2017
Start date
Feb 2006
Primary completion
Jan 2021
Completion
Jan 2022
Last update
Apr 13, 2023

Study contacts

Officials Officials, Officials
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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