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Trial Title:
Intestinal Metaplasia Cohort for Gastric Cancer Prediction
NCT ID:
NCT06075199
Condition:
Intestinal Metaplasia of Gastric Mucosa
Conditions: Official terms:
Metaplasia
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Detailed description:
Patients visiting Seoul National University Hospital, who have previously received an
incidental diagnosis of intestinal metaplasia during a prior gastroscopy examination,
will be considered as potential candidates for this study. Upon obtaining their informed
consent to participate, the initial endoscopy procedure will involve the collection of
biopsies to ensure an accurate histological diagnosis of intestinal metaplasia. These
biopsies will be taken from the antrum and body of the stomach, according to the protocol
of the updated Sydney system, to pathologically diagnose the extent and severity of
intestinal metaplasia. One to two pieces of tissue remaining from this diagnostic process
will be retained for future analysis. Subsequently, patients will be followed up on an
outpatient basis to track the development of gastric cancer through routine screening
endoscopies. In cases where patients develop gastric cancer, a comparative analysis will
be conducted with those who do not develop gastric cancer, to determine the differences
in expression of markers in the gastric mucosal tissue that was collected during the
initial endoscopy. Our ultimate aim is to identify potential biomarkers that may serve as
predictive indicators for the development of gastric cancer in patients with a
preexisting diagnosis of intestinal metaplasia.
Criteria for eligibility:
Study pop:
Outpatient clinic visitors
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients who visit Seoul National University Hospital
- Patients who have been visually diagnosed with intestinal metaplasia at a prior exam
Exclusion Criteria:
- Patients who have been previously diagnosed with gastric cancer or adenoma
- Patients who have previously received gastrectomy
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Soo-Jeong Cho, MD, PhD
Phone:
02-2072-4073
Email:
crystal5@snu.ac.kr
Start date:
September 13, 2023
Completion date:
June 30, 2033
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06075199
