- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00498134
Chemoprevention of Gastric Cancer by Intervention With Helicobacter Pylori and Cyclooxygenase Pathway
July 6, 2010 updated by: Hospital Authority, Hong Kong
Gastric cancer is the second leading cause of cancer deaths in the World.
In China, gastric cancer exceeds all other cancer mortality except lung cancer.
Helicobacter pylori infection is an important cause of gastric cancer.
We have previously started a randomized placebo-controlled chemoprevention trial in Changle in 1994 to address the issue of whether eradication of H. pylori alone is able to prevent or reduce the risk of gastric cancer.
The project involved 1600 subjects and is still ongoing.
On the other hand, our laboratory research indicated that an abnormally high expression of an enzyme cyclooxygenase-2 was found in gastric cancer and inhibition of this enzyme by a new drug (specific cyclooxygenase-2 inhibitor) could kill the cancer cells.
The same drug is approved now for use in treatment of hereditary colon cancer syndrome (Familial Adenomatous Polyposis, FAP), in the same rationale of tumour suppressive property of this drug.
We are now initiating a second chemoprevention study to assess the addition of this specific cyclooxygenase-2 inhibitor together with eradication of H. pylori on prevention or reduction of the risk of gastric cancer and to assess whether the combination can reverse pre-cancerous lesions in the stomach in the high-risk population.
The proposed site is Shangdong, China with very high prevalence of pre-cancerous lesions in asymptomatic H. pylori carriers.
We plan to recruit 1500 H. pylori positive subjects for this randomized placebo-controlled study.
H. pylori carriers will be randomized to receive treatment for the infection or placebo, followed by specific COX-2 inhibitor or placebo for 3 years.
The results will have significant impact on prevention of gastric cancer on a national scale and worldwide.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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China, China
- China
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject demonstrates a willingness to participate in the study as indicated by written informed consent.
- Male or female subject is at least 45 years of age.
- Subject indicates a willingness to abstain from the use of all NSAIDs (including over-the-counter products) and aspirin for the duration of the study.
- Female subject of childbearing potential has been using an effective means of contraception for 1 week prior to the preliminary visit. She also has agreed to remain abstinent, or to use oral birth control pills or single-barrier contraception (partner using condom or subject using diaphragm, contraceptive sponge or IUD) beginning at the preliminary visit and continuing till the end of the study. Women who are postmenopausal or status post-hysterectomy or tubal ligation are exempt from this requirement. (Postmenopausal is defined as no menses for the previous 1 year. If cessation of menses is within 18 months, FSH must be documented as elevated into the postmenopausal range before entry).
- Subject is judged to be in stable health based on medical history, physical examination, and routine laboratory tests.
Exclusion Criteria:
According to medical history
- Subject has a bleeding diathesis or requires anticoagulant therapy.
- Subject has uncontrolled hypertension. (Note: Subjects with medically controlled hypertension [diastolic blood pressure <95 mm Hg, systolic blood pressure <165 mm Hg] may participate.)
- Subject has a history of stroke or transient ischemic attack within the past 2 years.
- Subject has a history of hepatitis/hepatic disease that has been active within the previous 2 years.
- Subject has angina or congestive heart failure, with symptoms that occur at rest or minimal activity, or has a history of myocardial infarction within the past 1 year.
- Subject has a history of neoplastic disease within the previous 10 years. Exceptions: subjects with malignancy successfully treated >10 years prior to screening, where, in the judgment of the investigator and treating physician, there has been no evidence of recurrence from the time of treatment through the time of screening.
- Subject has a history of esophageal or gastric surgery.
- Subject has undergone previous small or large bowel resection.
- Subject has a history of inflammatory bowel disease (ulcerative colitis or Crohn's disease).
- Subject is allergic to paracetamol or subject has hypersensitivity (e.g., all or part of the syndrome of nasal polyps, angioedema, and bronchospastic reactivity) to aspirin, paracetamol, or other NSAIDs. NOTE: Subjects with a history of idiosyncratic allergic reaction (e.g., rash) to a single NSAID in the past but who tolerated at least 2 other NSAID medications without hypersensitivity reactions may participate.
- Subject is expected to need chronic NSAID treatment during the trial and/or subject has been taking NSAIDs (including salicylates or other aspirin-containing compounds) on a chronic basis.
- Subject has had ongoing or is expected to require treatment with any of the following: Ticlopidine, clopidrogel, or regular doses of aspirin, including "low-dose" aspirin, e.g., to prevent complications of vascular disease. Subjects may not discontinue an established course of anti-platelet therapy in order to enter this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Regression or prevent progression of various precancerous gastric conditions including gastric atrophy, intestinal metaplasia and dysplasia
Time Frame: 3 years
|
3 years
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Changes in cell proliferation, apoptosis and oncogene expressions
Time Frame: 3 years
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3 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of gastric cancer in a high risk area
Time Frame: 5-10 years
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5-10 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shiu Kum Lam, Prof, Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Study Completion (ANTICIPATED)
April 1, 2013
Study Registration Dates
First Submitted
July 6, 2007
First Submitted That Met QC Criteria
July 6, 2007
First Posted (ESTIMATE)
July 9, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
July 7, 2010
Last Update Submitted That Met QC Criteria
July 6, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
Other Study ID Numbers
- EC1721-01
- HARECCTR0500053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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