OLGA and OLGIM Stage System for Gastric Cancer | NCT03380052

Studies
OLGA and OLGIM Stage System for Gastric Cancer

NCT03380052

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Apr 13, 2023Actual

Enrollment

2,900Actual

Phase

Not provided

Conditions

Stomach Neoplasms
Atrophic Gastritis
Intestinal Metaplasia

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006Actual

Primary Completion Date

Jan 2021Actual

Completion Date

Jan 2022Actual

First Submitted Date

Dec 16, 2017

First Submission Date that Met QC Criteria

Dec 16, 2017

First Posted Date

Dec 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2023

Last Update Posted Date

Apr 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nayoung Kim, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Name	Class
National Clinical Research Coordination Center, Seoul, Korea	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,900Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	per 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

history of previous gastrointestinal surgery,
any other malignancy
cardia cancer
who do not perform endoscopic biopsy
pathologically proven gastric dysplasia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Officials Officials, Officials	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463-707	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D005757	Gastritis, Atrophic

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

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Browse Branches

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