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Gastric CancerPhase 3HELPERNCT02112214

Helicobacter Pylori Eradication for Gastric Cancer Prevention in the General Population

A Phase 3 study testing 10-day bismuth-based quadruple therapy in people with Gastric Cancer and Helicobacter Pylori Infection, run by National Cancer Center, Korea at 11 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of this study is to define the role of H. pylori eradication in the prevention of gastric cancer and its precursors in the context of a population-based endoscopic screening program. Read more about this study

Who is it for?
Ages 40 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Gastric Cancer, Helicobacter Pylori Infection
What is being tested?
10-day bismuth-based quadruple therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,224 participants
Where
11 sitesSouth Korea
Study dates
Jun 2014to Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men and women aged 40-65 who are invited to participate in the National Cancer Screening Program and receive upper endoscopy
  • Willingness to sign an informed consent form
  • Good health, as determined by medical history and physical examination at enrollment

Who cannot join

  • Personal history of gastric cancer
  • Family history of gastric cancer in a first degree relative
  • Diagnosis and active treatment for other organ cancer except carcinoma in situ within 5 years
  • Current treatment for serious medical condition which could hinder participation (such as liver cirrhosis, renal failure, pulmonary dysfunction including COPD or asthma, or uncontrolled infection)
  • Inadequate cardiovascular function including (a) New York Heart Association class III or IV heart disease, (b) unstable angina or myocardial infarction history, (c) history of significant ventricular arrhythmia requiring medication with antiarrhythmics, and (d) history of cerebrovascular accident
  • Requirement for therapeutic anticoagulant therapy, aspirin
Show all 15Show fewer
  • Gastric resections due to benign disease
  • H. pylori eradication therapy history
  • Mental incompetence to understand and sign informed consent
  • Alcoholism, drug abuse
  • Serious chronic diseases according to the evaluation of the study physician
  • Presence of a contraindication to the use of eradication treatment regimens
  • Inability to provide an informed consent
  • Pregnant or lactating women
  • Treatment required due to peptic ulcer, gastric cancer or esophageal cancer identified during the endoscopic examination

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

South Korea11 sites

  • Kosin University Gospel Hospital

    Busan, 49267

  • Pusan National University Hospital

    Busan, 620-739

  • Hallym University Chuncheon Sacred Heart Hospital

    Chuncheon, 24253

  • Kyungpook National University Hospital

    Daegu, 702-911

  • National Cancer Center

    Goyang, 410-769

  • Chonnam National University Hospital

    Gwangju, 501-757

  • Incheon St.Mary's Hospital/The Catholic University

    Incheon, 21431

  • Kandong Sacred Heart Hospital

    Seoul, 05355

  • SMG-SNU Boramae Medical Center

    Seoul, 07061

  • Chung-Ang University Hospital

    Seoul, 156-861

  • Uijeongbu St. Mary's Hospital/The Catholic University

    Uijeongbu-si, 480-821

Other trials in South Korea

About this study

Official title: Effect of Helicobacter Pylori Eradication on Gastric Cancer Prevention in Korea: a Randomized Controlled Clinical Trial

The aim of this study is to define the role of H. pylori eradication in the prevention of gastric cancer and its precursors in the context of a population-based endoscopic screening program.

Read the detailed description

Despite the decreasing incidence observed in the US and West European countries, gastric cancer is still an important global public health problem, especially in East Asian countries, where the burden of the disease is substantial. In the Republic of Korea, gastric cancer remains the leading cause of cancer in men and the fourth most common cancer in women. There is sufficient epidemiological and experimental evidence supporting a causal link between bacterial infection with H. pylori and gastric cancer development. However, evidence from clinical trials on the efficacy of H. pylori eradication with antimicrobial therapy to reduce the risk of gastric cancer is still limited. In addition, the beneficial or deleterious health impact of mass eradication at the population level has not been defined. In Korea, the prevalence of H. pylori infection in adults is still relatively high (~60%, >16 years old), and despite important reductions in mortality attributed to the screening program, incidence of gastric cancer remains elevated.

The investigators propose to conduct a randomized controlled clinical trial in Korea to evaluate the efficacy of H. pylori eradication to prevent gastric cancer incidence in different population subgroups including age and baseline gastric pathology. This study will be conducted in the context of the National Cancer Screening Program and the Korean Central Cancer Registry.

The proposed study will be a collaborative investigation between the National Cancer Center, Korea and the International Agency for Research on Cancer of the World Health Organization.

Being tested
10-day bismuth-based quadruple therapy, Placebo
Keywords
Helicobacter pylori treatment, Gastric cancer, Screening
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 10-day bismuth-based quadruple therapyDrug

    Also called Bismuth-based quadruple therapy

    Bismuth 300 mg (4 times a day), lansoprazole 30 mg (twice a day), metronidazole 500 mg (3 times a day), and tetracycline 500 mg (4 times a day) for 10 days

  • PlaceboOther

    Placebo for bismuth-based quadruple therapy

Study groups in NCT02112214
Study groupRoleWhat they receive
Intervention groupActive comparator10-day bismuth-based quadruple therapy for H. pylori positive subjects
Receives: Drug: 10-day bismuth-based quadruple therapy
Placebo groupPlacebo comparatorPlacebo for H. pylori positive subjects
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of gastric cancer between the intervention and placebo groups

    Histologically confirmed gastric adenocarcinoma stage 1A or more advanced defined at endoscopy or through cancer registry

    Measured: Up to 10 years After H. pylori eradication

Secondary outcomes (6)

  1. Incidence of gastric dysplasia

    Diagnosis of histologically confirmed gastric dysplasia

    Measured: Up to 10 years After H. pylori eradication

  2. Occurrence of adverse events caused by antibiotic treatment

    Solicited/unsolicited adverse events

    Measured: During 10 days of H. pylori eradication, and Up To 1 month after the treatment completion

  3. Incidence and mortality from other medical conditions such as obesity, diabetes, circulatory diseases, oesophageal diseases as well as other cancers and cognitive impairment

    Assessed through record linkage or direct assessment during screening visits

    Measured: Up to 10 years After H. pylori eradication

  4. Mortality from gastric cancer

    Cancer registry or other reports

    Measured: Up to 10 years after eradication

  5. All-cause mortality

    Korean National Health Insurance records or other reports

    Measured: Up to 10 years After H. pylori eradication

  6. Modification of atrophy score

    Change in histologic atrophy grade from enrollment to subsequent endoscopic assessment

    Measured: Up to 10 years After H. pylori eradication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
5,224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02112214
Sponsor's protocol ID
NCCCTS13716
Other IDs
1311240
Acronym
HELPER
Status last verified
Dec 2024
First submitted
3 Apr 2014
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 10-day bismuth-based quadruple therapy in people with Gastric Cancer and Helicobacter Pylori Infection, run by National Cancer Center, Korea at 11 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of gastric cancer between the intervention and placebo groups (time frame: Up to 10 years After H. pylori eradication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02112214.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.

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