Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2026-06-16 @ 8:35 PM
Study NCT ID:
NCT03188406
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2017-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric Cancer Precursor Lesions (GCPL) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D005757', 'term': 'Gastritis, Atrophic'}], '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': 'D005756', 'term': 'Gastritis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'gastric tissue, serum, plasma, buffy coat, saliva, urine, and stool.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-17', 'studyFirstSubmitDate': '2017-06-14', 'studyFirstSubmitQcDate': '2017-06-14', 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histological diagnosis', 'timeFrame': 'At enrollment', 'description': 'Advanced intestinal metaplasia'}]}, 'conditionsModule': {'keywords': ['Gastric Intestinal Metaplasia', 'Epidemiology', 'Risk stratification', 'Helicobacter pylori', 'Precancerous lesions', 'Gastric atrophy'], 'conditions': ['Intestinal Metaplasia', 'Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '1458460', 'type': 'BACKGROUND', 'citation': 'Correa P. Human gastric carcinogenesis: a multistep and multifactorial process--First American Cancer Society Award Lecture on Cancer Epidemiology and Prevention. Cancer Res. 1992 Dec 15;52(24):6735-40.'}, {'pmid': '23280711', 'type': 'BACKGROUND', 'citation': 'Gonzalez CA, Sanz-Anquela JM, Gisbert JP, Correa P. Utility of subtyping intestinal metaplasia as marker of gastric cancer risk. A review of the evidence. Int J Cancer. 2013 Sep 1;133(5):1023-32. doi: 10.1002/ijc.28003. Epub 2013 Feb 5.'}, {'pmid': '23224270', 'type': 'BACKGROUND', 'citation': 'Bonequi P, Meneses-Gonzalez F, Correa P, Rabkin CS, Camargo MC. Risk factors for gastric cancer in Latin America: a meta-analysis. Cancer Causes Control. 2013 Feb;24(2):217-31. doi: 10.1007/s10552-012-0110-z. Epub 2012 Dec 7.'}, {'pmid': '20381801', 'type': 'BACKGROUND', 'citation': 'Capelle LG, de Vries AC, Haringsma J, Ter Borg F, de Vries RA, Bruno MJ, van Dekken H, Meijer J, van Grieken NC, Kuipers EJ. The staging of gastritis with the OLGA system by using intestinal metaplasia as an accurate alternative for atrophic gastritis. Gastrointest Endosc. 2010 Jun;71(7):1150-8. doi: 10.1016/j.gie.2009.12.029. Epub 2010 Apr 9.'}, {'pmid': '18424244', 'type': 'BACKGROUND', 'citation': 'Rugge M, Correa P, Di Mario F, El-Omar E, Fiocca R, Geboes K, Genta RM, Graham DY, Hattori T, Malfertheiner P, Nakajima S, Sipponen P, Sung J, Weinstein W, Vieth M. OLGA staging for gastritis: a tutorial. Dig Liver Dis. 2008 Aug;40(8):650-8. doi: 10.1016/j.dld.2008.02.030.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nGastric cancer is a leading cause of cancer deaths around the world. This disease is a serious problem in places like East Asia, Central and South America, and Eastern Europe. Researchers want to study the causes of gastric cancer and its precursors. They want to reduce the number of people with stomach cancer.\n\nObjectives:\n\nTo learn more about bacteria factors and other causes of gastric cancer. To study potential markers associated with precancerous gastric lesions (intestinal metaplasia).\n\nEligibility:\n\nAdults ages 40-70 years at certain hospitals in Chile who:\n\nAre going to have upper gastrointestinal endoscopies\n\nOR have stomach cancer and need surgery\n\nDesign:\n\nParticipants will give gastric tissue samples.\n\nSome participants will donate a portion of the stomach tissue that is removed as part of their clinical care.\n\nParticipants will give access to reports of their stomach exam. They will allow researchers to photograph the microscope slides of their tissue samples.\n\nParticipants will answer questions. The topics of the questions include:\n\nAge, height, weight\n\nEducation\n\nHabits including tobacco and alcohol\n\nPersonal and family history of disease\n\nReproductive history\n\nDiet\n\nSome participants will give blood, urine, saliva, and stool samples. Study staff will collect the blood. They will tell the participants how to collect the other samples themselves.', 'detailedDescription': 'The burden of gastric adenocarcinoma is unevenly distributed, with several Asian and Latin American countries having particularly high incidence rates. Although chronic infection with Helicobacter pylori is the primary cause of this cancer, environmental and host cofactors modify the course of infection and determine whether infected individuals develop cancer. Due to the lack of adequate screening strategies and consequent late diagnosis, trends in mortality are similar to incidence, making this neoplasia the third leading cause of cancer death worldwide. The International Agency for Research on Cancer predicts that there will be no reduction in gastric cancer cases until at least 2030 due to population growth and aging. H. pylori-related gastric carcinogenesis is a multi-step process and mucosal lesions of intestinal metaplasia (IM) and dysplasia confer increased risk of progression. Therefore, case-control studies of these premalignant lesions may provide insights into cancer etiology and inform risk stratification. In addition, biomarkers to identify high-risk individuals are needed for early detection and curative treatment. Accordingly, we propose a 3-year study of Chilean adults undergoing upper gastrointestinal endoscopy for clinical purposes to identify 600 subjects with advanced premalignant lesions (i.e., incomplete-type IM, complete-type IM with extension to gastric corpus and dysplasia) for informative comparisons with 600 controls with non-atrophic gastritis, a benign histologic change apparent in most H. pylori infected individuals. As an additional case group, 100 individuals with newly diagnosed gastric cancer will be recruited from the same clinics. This multidisciplinary project will simultaneously evaluate bacterial, host and environmental factors towards a better understanding of gastric cancer etiology that may guide future efforts for prevention and control. We will explore risk factors that have been insufficiently studied, such as various hormones, H. pylori genomics, non- H. pylori gastric microbiota, and other parasitic infections. We will also evaluate potential noninvasive screening markers, including pepsinogens, hormones, miRNAs and DNA methylation. Results from this study may lead to improved management recommendations for individuals with advanced IM. Additionally, the resulting biobank of gastric tissue, blood, urine, saliva and stool will enable state-of-the-art molecular assays and serve as a resource for future research in this area.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending gastroenterology services.', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nTwo groups of symptomatic patients aged 40 to 70 years old, who are long term residents of a high gastric cancer risk area:\n\n* Approximately 1300 patients who need upper endoscopy (examination of the lining of the stomach with a flexible tube).\n* Approximately 100 patients recently diagnosed with stomach cancer who need surgery as treatment for the disease.\n\nEXCLUSION CRITERIA:\n\n* Pregnant women\n* Children'}, 'identificationModule': {'nctId': 'NCT03188406', 'briefTitle': 'Gastric Cancer Precursor Lesions (GCPL) Study', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Gastric Cancer Precursor Lesions (GCPL) Study', 'orgStudyIdInfo': {'id': 'NCI-2020-07070'}, 'secondaryIdInfos': [{'id': '17-C-N094'}, {'id': '999917094', 'type': 'OTHER', 'domain': 'National Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastric cancer', 'description': 'Patients with clinical or histological diagnosis of stomach cancer'}, {'label': 'Gastric intestinal metaplasia', 'description': 'Patients classified as OLGIM \\>0'}, {'label': 'Non-atrophic gastritis', 'description': 'Patients classified as OLGA 0'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Concepción', 'country': 'Chile', 'facility': 'Universidad de Concepción', 'geoPoint': {'lat': -36.82699, 'lon': -73.04977}}, {'city': 'Curanilahue', 'country': 'Chile', 'facility': 'Hospital de Curanilahue', 'geoPoint': {'lat': -37.47793, 'lon': -73.34495}}, {'city': 'Nueva Imperial', 'country': 'Chile', 'facility': 'Hospital Intercultural', 'geoPoint': {'lat': -38.74451, 'lon': -72.95025}}, {'city': 'Port Montt', 'country': 'Chile', 'facility': 'Hospital de Puerto Montt', 'geoPoint': {'lat': -41.4693, 'lon': -72.94237}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Hospital San Juan de Dios', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Pontificia Universidad Catolica', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Temuco', 'country': 'Chile', 'facility': 'Hospital de Temuco', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}, {'city': 'Victoria', 'country': 'Chile', 'facility': 'Hospital de Victoria', 'geoPoint': {'lat': -38.23291, 'lon': -72.33292}}, {'city': 'Villarrica', 'country': 'Chile', 'facility': 'Hospital de Villarrica', 'geoPoint': {'lat': -39.28569, 'lon': -72.2279}}], 'overallOfficials': [{'name': 'M. Constanza Camargo, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U.S. National Cancer Institute (NCI)'}, {'name': 'Alejandro Corvalan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pontificia Universidad Catolica (Chile)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}