Free stomach infection test and treatment could prevent cancer in at-risk communities
NCT ID NCT07224035
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study screens 500 adults in South Florida for H. pylori, a stomach infection that can lead to chronic gastritis, ulcers, and gastric cancer. Those who test positive receive free treatment with a three-drug combination (VOQUEZNA® Triple Pak®) for 14 days. The goal is to see if screening and early treatment can prevent serious stomach diseases.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VOQUEZNA® Triple Pak® (vonoprazan, amoxicillin, clarithromycin) and PYtest® 14C-Urea Breath Test
- What this could lead to
- If successful, this could show that widespread screening and treatment of H. pylori reduces the risk of stomach cancer and other complications in high-risk communities.
- What could go wrong
- This is a single-site study with 500 participants, so results may not apply to all populations. The treatment requires a 14-day course of antibiotics, which can cause side effects like diarrhea or allergic reactions.
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.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
-
Nov 2027
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
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 ≥ 18 years of age Exclusion Criteria: * Adults with a personal history of gastric cancer * Adults with prior history of H. Pylori (HP) treatment and confirmed eradication * Adults unable to consent * Adults unable to consent in their preferred language * Pregnant women, those who are breastfeeding, or those who are planning to become pregnant/breastfeed * Prisoners * Persons who are allergic, hypersensitive, or unable to take any of the components of the medication regimen VOQUEZNA® Triple Pak®: * vonoprazan * amoxicillin or any other beta-lactams (e.g. penicillins and cephalosporins) * clarithromycin or any other macrolide antimicrobial (e.g. erythromycin) * Persons presently taking any of the following: * Rilpivirine-containing products * Pimozide * Lomitapide, lovastatin, simvastatin, atorvastatin, and pravastatin * Ergot alkaloids * Colchicine (if with kidney or liver impairment) * Lurasidone * Drugs known to prolong the QT interval (e.g., pimozide). * Class IA (e.g., quinidine, procainamide, disopyramide) or Class III (e.g., dofetilide, amiodarone, sotalol) antiarrhythmic agents * Verapamil, amlodipine, diltiazem, nifedipine * Nateglinide, pioglitazone, repaglinide, rosiglitazone, and insulin * Quetiapine * Warfarin * Benzodiazepines (e.g. triazolam, midazolam) * Persons who have any of the following, as they may be prone to adverse effects from the medication regimen: * History of cholestatic jaundice * Severe kidney impairment * Severe hepatic impairment * Participants with known prolongation of QT interval, ventricular cardiac arrhythmia, including torsades de pointes. * Participants with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia * Participants with ongoing mononucleosis
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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.
Contacts and locations
Locations
-
University of Miami
Miami, Florida, 33136, United States
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