Pepsinogen II and Helicobacter Pylori Test in Gastric Cancer

NCT06301464 | Active Not Recruiting

• 1 other identifier: B-2003-603-103
• Study Type: observational
• Target: 24,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study to validate the role of pepsinogens in gastric cancer screening.

Conditions

Gastric Cancer

Keywords

Gastric cancer; Pepsinogen; Helicobacter pylori

Outcome Measures

Primary Outcomes (1)

• The level of serum pepsinogens

  To compare the level of serum pepsinogens between the two groups

  At the time of enrollment

Study Arms (2)

Patients with gastric neoplasms

Patients with gastric neoplasms

Normal control

Normal control without gastric neoplasms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have undergone a blood test for serum pepsinogens and anti-H. pylori antibody, have undergone an esophagogastroduodenoscopy test three months before and after the blood test, have no other reason for exclusion, and have agreed to participate in the study

You may qualify if:

• Who undergoes serum pepsinogens and anti-H. pylori antibody tests, and esophagogastroduodenoscopy during a health-screening examination at Seoul National University Hospital Gangnam center (SNUHGC) or Seoul National University Bundang Hospital (SNUBH)

You may not qualify if:

• Who do not receive serum pepsinogens or anti-H. pylori antibody studies
• Who do not receive esophagogastroduodenoscopy within 3 months before or after the date of serum pepsinogens and anti-H. pylori antibody tests
• Subjects with recent proton-pump inhibitor therapy 1 month prior to enrollment
• Subjects with prior history of gastrectomy
• Subjects with upper gastrointestinal neoplasms other than gastric adenoma/adenocarcinoma
• Subjects who do not agree to participate in the study or withdraw his/her consent

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum pepsinogens and anti-H. pylori antibody

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Nayoung Kim, M.D., Ph.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 8, 2024
• Study Start: March 1, 2003
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)