Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-01 @ 8:11 PM
Study NCT ID:
NCT01813994
Status:
COMPLETED
Last Update Posted:
2019-03-29
First Post:
2013-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Statin on the Gastric Inflammation in Patients at High Risk of Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D005756', 'term': 'Gastritis'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2013-03-07', 'studyFirstSubmitQcDate': '2013-03-14', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of the patients with high-risk (III/IV) OLGA stages', 'timeFrame': '6 months from the start of taking the statins', 'description': 'patients with high-risk OLGA stages will be assessed by histologic examinations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Statin; Gastric inflammation; Gastric cancer'], 'conditions': ['Early Gastric Cancer or Gastric Adenoma']}, 'descriptionModule': {'briefSummary': 'Statins are commonly used as cholesterol-lowering medications and have shown effectiveness in the primary and secondary prevention of heart attack and stroke. In addition, several recent studies of human cancer cell lines and animal tumor models indicate that statins may have chemopreventive properties through the arresting of cell-cycle progression. The chemopreventive effect of statins was demonstrated in some kind of human tumors including colorectal cancer. In addition, recent one large epidemiologic study showed that statins decreased risk of gastric cancer. On the other hands, it has been well known that Helicobacter pylori infection induces gastric atrophy and intestinal metaplasia, which are premalignant lesions of gastric cancer. Progression of these premalignant lesions could be limited by H. pylori eradication. In addition, a recent double blind randomization study revealed that simvastatin as adjuvant to standard therapy improves significantly the H. pylori eradication rate. Therefore, investigators conjecture that statins may have an adjuvant role for inhibition of gastric carcinogenesis. investigators aim to evaluate the role of statins in gastric carcinogenesis by observing the changes of gastric inflammation under statins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age, between 20 and 70\n2. Early gastric cancer or adenoma which is achieved curative resection by endoscopic submucosal dissection\n3. ECOG performance status 0 or 1\n\nExclusion Criteria:\n\n1. Previous subtotal gastrectomy or gastrostomy\n2. Repeated endoscopic submucosal dissection\n3. Two or more synchronous lesions\n4. Presence of gastric or duodenal ulcer except artificial ulcer due to endoscopic submucosal dissection\n5. History of drugs which are able to induce gastric ulcer including aspirin, NSAIDs, and steroid (30 days or more, within 1 year at the time of screening\n6. Indication of statins, including dyslipidemia, myocardial infarction, and heart failure.\n7. Develop of complications caused by endoscopic submucosal dissection, including bleeding, perforation, and pneumonia\n8. LDL \\< 70 mg/dL\n9. Allergy to statins\n10. Pregnancy or breast milk feeding\n11. Active infection\n12. Significant cardiopulmonary disease\n13. Active hepatitis or severe hepatic dysfunction\n14. Severe renal dysfunction\n15. Severe bone marrow dysfunction'}, 'identificationModule': {'nctId': 'NCT01813994', 'briefTitle': 'Role of Statin on the Gastric Inflammation in Patients at High Risk of Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2012-0889'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Without simvastatin', 'interventionNames': ['Drug: Arm2: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Statin group', 'description': 'With simvastatin', 'interventionNames': ['Drug: Arm1: Statin']}], 'interventions': [{'name': 'Arm1: Statin', 'type': 'DRUG', 'description': 'Study1 (only H. pylori infected patients) Arm1: All patients undergo H. pylori eradication therapy after 2 weeks from the endoscopic submucosal dissection. In this arm2, all patients take statins for 6 months. Then, follow-up endoscopy for gastric biopsy and CLO test will be performed after 6.5 months from the endoscopic submucosal dissection.\n\nStudy2 (only H. pylori non-infected patients) Arm1: In this arm2, all patients start taking statins after 2 weeks from the endoscopic submucosal dissection. Follow-up endoscopy for gastric biopsy will be performed after 6.5 months from the endoscopic submucosal dissection.', 'armGroupLabels': ['Statin group']}, {'name': 'Arm2: Placebo', 'type': 'DRUG', 'otherNames': ['C10AA-Hmg coa reductase inhibitors'], 'description': 'Study1 (only H. pylori infected patients) Arm2: All patients undergo H. pylori eradication therapy after 2 weeks from the endoscopic submucosal dissection. In this arm2, all patients take placebos for 6 months. Then, follow-up endoscopy for gastric biopsy and CLO test will be performed after 6.5 months from the endoscopic submucosal dissection.\n\nStudy2 (only H. pylori non-infected patients) Arm2: In this arm2, all patients start taking placebos after 2 weeks from the endoscopic submucosal dissection. Follow-up endoscopy for gastric biopsy will be performed after 6.5 months from the endoscopic submucosal dissection.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}