NCT02407119Active, not recruitingPhase 3
Effects of H. Pylori Eradication on the Gastric Preneoplastic Lesion and Neoplasm After ESD
Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Metachronous Cancer in Patients Undergoing Endoscopic Mucosal Resection for Gastric Cancer
Source: ClinicalTrials.gov · Last updated 9 Nov 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 470 (actual)
- First submitted
- 13 Mar 2015
- Start date
- 1 Jun 2003
- Primary completion date
- 30 Jun 2016
- Lead sponsor
- National Cancer Center, Korea
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT02407119
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 470
- From 1 Jun 2003 to the primary completion date, 30 Jun 2016
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous serious side effect to antibiotics
- Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases
Other illness
- Recurrent gastric cancer
- Undergoing operation due to remnant cancer
- Other malignancy within the past 5 years
- Psychiatric disorder that would preclude compliance
Other
- H. pylori eradication treatment history
- Poorly differentiated adenocarcinoma or Signet ring cell carcinoma
- Undergoing operation due to complication of EMR
- Pregnant or nursing women
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center - Korea Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.