Stomach bug clues: can infection patterns forecast early cancer behavior?
NCT ID NCT07724496
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This study looks at whether the presence and distribution of H. pylori bacteria in the stomach, along with tissue features of early gastric cancer, can help predict how the cancer will behave and what the long-term outlook may be. Researchers will analyze data from about 1,500 people who had or will have early-stage stomach cancer removed via endoscopy. The goal is to see if combining infection status and pathology can better forecast recurrence or new cancers after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors better predict which early gastric cancers are more aggressive and tailor follow-up care after endoscopic removal.
- What could go wrong
- This is an observational study, not a treatment trial, so it cannot prove cause and effect. Results may not apply to all patients or lead to immediate changes in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 1,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2024
- Expected to finish
-
Dec 2031
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adults aged 18 to 80 years with early gastric cancer, high-grade intraepithelial neoplasia, or other gastric neoplastic lesions treated with or scheduled for endoscopic submucosal dissection at participating medical centers. The study will include approximately 1000 retrospectively identified participants with available clinical, endoscopic, pathological, H. pylori testing, and follow-up records, and approximately 500 prospectively enrolled participants. H. pylori infection and eradication status, tissue-based and intragastric H. pylori distribution, pathological features, gastric cancer subtype, biological behavior, ESD curability, and outcomes at 1, 2, and 3 years after ESD and during long-term follow-up will be evaluated.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults aged 18 to 80 years * Retrospectively identified or prospectively enrolled patients with early gastric cancer, high-grade intraepithelial neoplasia, or other gastric neoplastic lesions treated with or scheduled for endoscopic submucosal dissection according to standard clinical indications at participating medical centers * Availability or planned availability of sufficient Helicobacter pylori assessment data for study classification, including 13C-urea breath test, serum Helicobacter pylori IgG antibody testing, pathological assessment of gastric tissue, prior H. pylori infection history, prior eradication history, eradication confirmation, or follow-up H. pylori testing results when available * Availability or planned availability of gastric tissue pathological assessment from routine biopsy specimens and/or endoscopic submucosal dissection specimens for evaluation of tissue-based H. pylori detection, background mucosal changes, lesion pathological characteristics, and ESD-related pathological findings * Availability or planned availability of key clinical, endoscopic, and pathological information required to evaluate gastric cancer subtype, biological behavior, and curability after ESD, including lesion location, histological subtype, differentiation, depth of invasion, lymphovascular invasion, margin status, curative resection status, and additional treatment information when available * Availability of follow-up data for retrospectively included participants, or willingness and ability to participate in follow-up evaluations for prospectively enrolled participants, including endoscopic follow-up at approximately 1, 2, and 3 years after ESD and longer-term follow-up when available * Adequate cardiac, hepatic, renal, and pulmonary function to tolerate endoscopic treatment and routine follow-up for prospectively enrolled participants scheduled for ESD * Ability to provide written informed consent for prospectively enrolled participants, or availability of ethics-approved retrospective clinical data for retrospectively included participants Exclusion Criteria: * Patients whose final diagnosis does not meet the study population definition, including those without early gastric cancer, high-grade intraepithelial neoplasia, or other eligible gastric neoplastic lesions * Insufficient clinical, H. pylori testing, endoscopic, pathological, or follow-up information to classify H. pylori infection or eradication status or to evaluate the main study outcomes * Lack of adequate pathological material or pathological information for assessment of gastric lesion characteristics, tissue-based H. pylori detection, or background mucosal changes * Previous gastrectomy or major gastric surgery that substantially alters gastric anatomy and prevents reliable assessment of lesion location, intragastric distribution, or background mucosal status * For prospectively enrolled participants scheduled for ESD, severe comorbid conditions, such as uncontrolled cardiovascular or cerebrovascular disease, severe coagulopathy, or very poor general condition, that make endoscopic submucosal dissection unsafe * For prospectively enrolled participants scheduled for ESD, anticoagulant or antiplatelet therapy that cannot be safely interrupted or managed during the perioperative period, or active bleeding tendency judged to significantly increase procedural risk * Pregnancy or breastfeeding for prospectively enrolled participants * Inability or unwillingness to comply with study procedures or follow-up requirements for prospectively enrolled participants * Any other condition judged by the investigators to make the participant unsuitable for the study
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Early gastric cancer are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
3 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Department of Gastroenterology, Rocket Force Characteristic Medical Center
RECRUITINGBeijing, Beijing Municipality, China
-
First Medical Center of Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, 100853, China
-
The Eighth Medical Center of Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, 100039, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can western patients skip surgery for early stomach cancer?
- Can an AI eye guide surgeons to safer, faster cancer removal?
- Which treatment for early stomach cancer offers the best Long-Term survival?
- Shorter h. pylori treatment shows promise in new trial
- Fluorescent dye guides Stomach-Sparing surgery for early cancer
- New Dual-Scope surgery shows promise for early stomach cancer