Active — Not RecruitingPhase 3

Effects of H. Pylori Eradication on the Gastric Preneoplastic Lesion and Neoplasm After ESD

South Korea470 participantsStarted 2003-06

Plain-language summary

This study evaluates whether Helicobacter pylori eradication improves precancerous lesions including glandular atrophy and intestinal metaplasia as well as metachronous cancers or dysplasias after endoscopic mucosal resection for gastric cancer.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Early Gastric cancer or high grade dysplasia confirmed by endoscopy * Histologically confirmed well or moderately differentiated adenocarcinoma, or high grade dysplasia * Submucosal invasion is not suspected * No evidence of ulceration or ulcer scar within the lesion * Helicobacter pylori infection was confirmed by histological evaluation and rapid urease test * Pre op CT stage: IA (T1N0M0) according to UICC TNM classification system * Informed consent should be signed Exclusion Criteria: * Recurrent gastric cancer * Previous serious side effect to antibiotics * H. pylori eradication treatment history * Poorly differentiated adenocarcinoma or Signet ring cell carcinoma * Undergoing operation due to complication of EMR * Undergoing operation due to remnant cancer * Other malignancy within the past 5 years * Pregnant or nursing women * Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases * Psychiatric disorder that would preclude compliance

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement (histological) of glandular atrophy

Timeframe: 3 years after enrollment

Incidence of metachronous gastric cancer

Timeframe: 3 years after last patient enrollment

Trial details

NCT IDNCT02407119

SponsorNational Cancer Center, Korea

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Helicobacter Pylori Infection trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.