Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-04-16 @ 2:13 AM
Study NCT ID:
NCT01774266
Status:
UNKNOWN
Last Update Posted:
2013-06-03
First Post:
2013-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Methylated Reprimo in Plasma for Asymptomatic Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and biopsy samples are collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-30', 'studyFirstSubmitDate': '2013-01-19', 'studyFirstSubmitQcDate': '2013-01-22', 'lastUpdatePostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Detection of H.pylori and gastric atrophy', 'timeFrame': '2 years', 'description': 'The rate of H.pylori detection and gastric atrophy based on serum levels of H.pylori and Pepsinogens I/II ratio.'}], 'primaryOutcomes': [{'measure': 'Early detection of gastric cancer', 'timeFrame': '2 years', 'description': 'Increase the frequency of early detection rate of gastric cancer'}], 'secondaryOutcomes': [{'measure': 'Monitoring progression of disease', 'timeFrame': '2 years', 'description': 'In the case in which diagnoses of gastric cancer will be made, the result of treatment will be measure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'DNA methylation', 'Reprimo', 'cell-free DNA', 'non-invasive'], 'conditions': ['Early Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '18829507', 'type': 'BACKGROUND', 'citation': 'Bernal C, Aguayo F, Villarroel C, Vargas M, Diaz I, Ossandon FJ, Santibanez E, Palma M, Aravena E, Barrientos C, Corvalan AH. Reprimo as a potential biomarker for early detection in gastric cancer. Clin Cancer Res. 2008 Oct 1;14(19):6264-9. doi: 10.1158/1078-0432.CCR-07-4522.'}, {'pmid': '23983680', 'type': 'DERIVED', 'citation': 'Carrasco G, Corvalan AH. Helicobacter pylori-Induced Chronic Gastritis and Assessing Risks for Gastric Cancer. Gastroenterol Res Pract. 2013;2013:393015. doi: 10.1155/2013/393015. Epub 2013 Jul 29.'}], 'seeAlsoLinks': [{'url': 'http://www.conicyt.cl/fondef/', 'label': 'search for project D09I1137'}]}, 'descriptionModule': {'briefSummary': 'In this proposal the investigators aim to develop a commercial kit to be used in primary screening and non-invasive triage for early detection of gastric cancer. This kit will be cost-effective and more accessible to the general population. In addition, the investigators would like to expand our current patent already submitted to INAPI (National Institute for Intellectual Property) and propose royalties to biomedical diagnostic companies for the use of our product at international level.', 'detailedDescription': "Gastric cancer is the first cause of death in Chile and the second worldwide. Currently, no screening methods are available for early detection of gastric cancer at population level. The only available test is serum levels of pepsinogen I/II for gastric atrophy, a precursor lesion only for intestinal type with low risk to progress to gastric cancer. The investigators' previous work, supported by FONDECYT (National Council for Research and Technology) and FONIS (National Council for Research and Development of Human Health) both from the Government of Chile led us to discover a potential biomarker for early detection of gastric cancer, Reprimo, a tumor suppressor gene related to p53 in the arrest of G2-M of the cell cycle (Clin Cancer Res. 2008;14:6264-9). Here, the investigators propose to evaluate plasmatic detection of Reprimo in conjunction with gastric atrophy markers and H.pylori detection to establish a novel screening and triage strategy for early detection of gastric cancer. The aims are i) to determine sensitivity and specificity for Reprimo in the detection of gastric cancer in a high-risk population evaluated by upper gastrointestinal endoscopy (1,000 males, 30-74 y.o. low income, symptomatic or asymptomatic) and ii) to characterize at clinical, pathological and molecular level cases of gastric cancer identified and non-identified by direct detection of Reprimo along with atrophy, H.pylori and clinical markers. With this information, the investigators will develop an algorithm for screening and triage evaluating predictive values of plasmatic detection of Reprimo versus atrophy \\& H.pylori detection and clinical data in a general population (3,000 male/female, 40-70 y.o.) from a high-risk area for gastric cancer in Chile. In this step the investigators will evaluate also acceptability, efficacy and efficiency of the proposed algorithm. In this proposal the investigators aim to develop a commercial kit to be used in primary screening and non-invasive triage for early detection of gastric cancer. This kit will be cost-effective and more accessible to the general population. In addition, the investigators would like to expand the investigators' current patent already submitted to INAPI and propose royalties to biomedical diagnostic companies for the use of the investigators' product at international level."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '3000 population base study from rural area in south of Chile. This is area has one of the highest incidence of gastric cancer in the world (35/100.000).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female\n* Age 40-70 y.o.\n\nExclusion Criteria:\n\n* Gastric Cancer\n* Dyspepsia\n* Bleeding disorders'}, 'identificationModule': {'nctId': 'NCT01774266', 'acronym': 'DEMRAC', 'briefTitle': 'Detection of Methylated Reprimo in Plasma for Asymptomatic Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Screening and Triage Test for Early Detection of Gastric Cancer', 'orgStudyIdInfo': {'id': 'D09I1137'}, 'secondaryIdInfos': [{'id': '11-156', 'type': 'OTHER', 'domain': 'CEI-MEDUC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Molina - Chile', 'description': 'Molina is one of the counties with the highest mortality rate of gastric cancer in Chile. Molina has a population of 40.000 hab mostly rural. Half of the population lives in Molina city and the other half in the suburbs. Molina is located near the Mountain Andes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8320000', 'city': 'Molina', 'state': 'Maule Region', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Alejandro Corvalan, M.D.', 'role': 'CONTACT', 'email': 'corvalan@med.puc.cl', 'phone': '56223548289'}, {'name': 'Paz Cook, R.N.', 'role': 'CONTACT', 'email': 'pcook@gmail.com', 'phone': '56223548289'}, {'name': 'Mauricio Olivera, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Santa Rosa de Molina', 'geoPoint': {'lat': -35.11428, 'lon': -71.28232}}], 'centralContacts': [{'name': 'Alejandro H. Corvalan, M.D.', 'role': 'CONTACT', 'email': 'corvalan@med.puc.cl', 'phone': '+56-02-354-8289'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministerio de Salud de Chile', 'class': 'UNKNOWN'}, {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, {'name': 'Red Salud UC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}