NCT06075199

Brief Summary

In this study, we aim to establish a prospective cohort of patients with endoscopically and histologically confirmed intestinal metaplasia, collect gastric mucosal tissue samples from this cohort, and follow the development of gastric cancer over time.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
87mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Sep 2023Jun 2033

Study Start

First participant enrolled

September 13, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2033

Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

9.8 years

First QC Date

October 3, 2023

Last Update Submit

November 26, 2024

Conditions

Intestinal Metaplasia of Gastric Mucosa

Outcome Measures

Primary Outcomes (1)

  • Gastric Cancer Development

    Number of Participants Who Develop Gastric Cancer

    10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Outpatient clinic visitors

You may qualify if:

  • Patients who visit Seoul National University Hospital
  • Patients who have been visually diagnosed with intestinal metaplasia at a prior exam

You may not qualify if:

  • Patients who have been previously diagnosed with gastric cancer or adenoma
  • Patients who have previously received gastrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Gastric mucosal tissue from the antrum and body of the stomach

Study Officials

  • Soo-Jeong Cho, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo-Jeong Cho, MD, PhD

CONTACT

02-2072-4073crystal5@snu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 10, 2023

Study Start

September 13, 2023

Primary Completion (Estimated)

June 30, 2033

Study Completion (Estimated)

June 30, 2033

Last Updated

November 29, 2024

Record last verified: 2024-11

Locations

KR(1)