Multicenter prospective cohort study to identify high-risk group for primary gastric cancer using DNA methylation levels in normal-appearing gastric tissues in healthy people after Helicobacter pylori eradication

Multicenter prospective cohort study to identify high-risk group for primary gastric cancer using DNA methylation levels in normal-appearing gastric tissues in healthy people after Helicobacter pylori eradication - Risk prediction of gastric cancer after H. pylori eradication

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016894

Enrollment

2000

Registered

2015-03-24

Start date

2015-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age of 20 to 75 years old at the time of enrollment. 2) ECOG PS of 0 or 1. 3) Past infection with H.pylori confirmed by urea breath test, rapid urease test, serum H.pylori IgG Ab, microscopic analysis of a gastric biopsy specimen, cultivation, a urine antibody test, or stool antigen test. 4) Eradicated for H. pylori in or after February 2013. 5) Chronic gastritis with an open-type atrophic change at the time of eradication. 6) Successful eradication of H.pylori confirmed by urea breath test or stool antigen test. 7) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies, except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 2) Past history of gastrectomy, endoscopic treatment of a gastric tumor, and reconstructive surgery with a stomach tube for an esophageal cancer. 3) Past history of receiving chemotherapy (including endocrinotherapy) or radiation therapy against any other malignancies. 4) Suspicious gastric tumor by endoscopy or gastric biopsy at the time of eradication. 5) Psychosis. 6) Systemic steroid medication. 7) Individuals with two or more kinds of antiplatelet medications, with anticoagulant medication, or with coagulopathy. 8) Active gastrointestinal bleeding. 9) Individuals considered unsuitable for biopsy by an endoscopist. 10) Individuals with hereditary gastrointestinal tumors, including familial adenomatous polyposis (FAP), Lynch syndrome or Hereditary non-polyposis colorectal cancer (HNPCC), Peutz-Jeghers syndrome, Cowden syndrome, and Hereditary diffuse gastric cancer.

Design outcomes

Primary

Measure	Time frame
The primary endpoint was an incidence rate of primary gastric cancer identified by annual endoscopy and confirmed by histology, and the primary objective was to compare the hazards in the highest quartile versus lowest quartile of DNA methylation levels of pre-selected marker genes.	—

Secondary

Measure	Time frame
A secondary objective was the determination of a cutoff DNA methylation level to identify a population with a super-high gastric cancer risk.	—

Countries

Japan

Contacts

Public ContactSeiichiro Abe

National Cancer Center Hospital, Tokyo, Japan Endoscopy Division

seabe@ncc.go.jp+81-3-3542-2511

Outcome results