[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530894":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":16,"studyPopulation":17,"armGroups":18,"interventions":28,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":368,"collaborators":370,"id":406,"slug":407,"hasResults":408,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":408,"sex":414,"minAge":415,"maxAge":11,"enrollmentInfo":416,"targetDuration":11,"studyType":419,"phases":11,"briefSummary":420,"conditions":421,"keywords":11,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":433},{"fullName":5,"class":6},"Centre Paul Strauss","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Number of participants with Gallbladder Cancer\u002FDysplasia development",null,"At inclusion or after pathological examination of the resected gallbladder",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":14,"timePerspective":15,"maskingInfo":11},"CASE_CONTROL","PROSPECTIVE","Gallbladder cancer (GBC) is a neglected disease with huge potential for prevention. This study aims at significantly improving the accuracy of risk estimation and early detection of GBC by identifying and adequately considering geographical, environmental, lifestyle, ethnic, gender and molecular differences. The investigators plan to generate the information needed to establish and refine current prevention programmes, including the primary, secondary and tertiary prevention of GBC. The investigators will (1) build a unique European-Latin American GBC biorepository integrated into a tailored IT platform, (2) identify, validate and functionally characterize novel GBC biomarkers, (3) develop a multifactorial risk score that integrates established and newly identified epidemiological and molecular risk factors, (4) improve the understanding of the causal mechanisms that link lifestyle, cultural and behavioural factors to GBC development, (5) unravel novel opportunities for the targeted therapy of incidental GBC, (6) exploit existing and newly generated epidemiological and multi-omics data to improve the accuracy of GBC risk prediction and (7) contribute to the training of the next generation of Latin American researchers in precision medicine for GBC. The generated information will permit identification of individuals at high GBC risk, guiding surveillance and individual decisions on the possible benefit of preventive gallbladder removal in regions of low and high GBC incidence. Novel data on genomic alterations in incidental GBC will pave the way towards implementation of future clinical trials. The planned European-Latin American GBC biorepository and IT platform will constitute a prime resource for translational research on individualized prevention, personalized early detection and targeted therapy of GBC. The participation in our project of representatives of health authorities, patients and the industry guarantee the efficient incorporation of project results into national health policies.\n\nThe study protocol has been approved by the Comité de Protection des Personnes, France, the ethics committees of Servicio de Salud Metropolitano Oriente, Servicio de Salud Metropolitano Sur Oriente and Servicio de Salud Metropolitano Central in Santiago de Chile, Servicio de Salud Coquimbo in Coquimbo, Chile, Servicio de Salud Maule in Talca, Chile, Universidad Católica del Maule in Talca, Chile, Servicio de Salud Concepción in Concepción, Chile, Servicio de Salud Araucanía Sur in Temuco, Chile, Servicio de Salud Valdivia in Chile, Centro de Bioética Universidad del Desarrollo and Clínica Alemana de Santiago in Santiago de Chile, Unidad de Investigación Hospital San Juan de Dios in Santiago de Chile, the Medical Faculties of Universidad de Chile and Pontificia Universidad Católica de Chile, Facultad de Medicina, Universidad Mayor de San Simón, Bolivia, Comité Provincial de Ética de Investigación de la Provincia de Jujuy, Argentina, and Comité de ética e Investigación del Instituto Nacional de Enfermedades Neoplásicas, Peru.","Participants are adults with GBC, gallbladder dysplasia, or cholelithiasis.",[19,24],{"label":20,"type":11,"description":21,"interventionNames":22},"Gallbladder Cancer\u002FDysplasia","Patients affected by gallbladder cancer or dysplasia, both before and after starting their treatment",[23],"Other: None, observational study.",{"label":25,"type":11,"description":26,"interventionNames":27},"Gallstone disease","Patients affected by cholelithiasis before cholecystectomy (only patients scheduled for cholecystectomy will be recruited)",[23],[29],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"None, observational study.","Epidemiological, clinical and dietary data will be collected along with blood, saliva, urine, bile, feces and gallbladder tissue samples.",[20,25],[34],{"name":35,"affiliation":36,"role":37},"Justo LORENZO BERMEJO, PhD","Heidelberg University Hospital (UKHD, Germany) and Centre Paul Strauss (CPS, France)","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":11,"email":43},"Dominique SCHERER, PhD","CONTACT","+49 6221 56 7303","scherer@imbi.uni-heidelberg.de",{"name":45,"role":41,"phone":46,"phoneExt":11,"email":47},"Carol BARAHONA PONCE, PhD","+49 6221 56 7616","barahona@imbi.uni-heidelberg.de",[49,64,71,81,93,100,107,114,121,133,143,153,163,173,183,190,197,204,211,218,225,232,239,246,256,266,273,280,295,307,314,321,331,338,348,358],{"facility":50,"status":51,"city":52,"state":11,"zip":11,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Hospital Papa 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Gastroenterológico",{"type":56,"coordinates":110},[88,89],{"lat":89,"lon":88},[113],{"name":63,"role":41,"phone":11,"phoneExt":11,"email":47},{"facility":115,"status":51,"city":83,"state":11,"zip":11,"country":84,"countryCode":85,"cosmosGeoPoint":116,"geoPoint":118,"contacts":119},"Instituto Oncológico Nacional",{"type":56,"coordinates":117},[88,89],{"lat":89,"lon":88},[120],{"name":63,"role":41,"phone":11,"phoneExt":11,"email":47},{"facility":122,"status":51,"city":123,"state":11,"zip":11,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Hospital Regional de Arica","Arica","Chile","CL",{"type":56,"coordinates":127},[128,129],-70.30058,-18.47552,{"lat":129,"lon":128},[132],{"name":63,"role":41,"phone":11,"phoneExt":11,"email":47},{"facility":134,"status":51,"city":135,"state":11,"zip":11,"country":124,"countryCode":125,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Hospital Regional de 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Luco",{"type":56,"coordinates":193},[178,179],{"lat":179,"lon":178},[196],{"name":63,"role":41,"phone":11,"phoneExt":11,"email":47},{"facility":198,"status":51,"city":175,"state":11,"zip":11,"country":124,"countryCode":125,"cosmosGeoPoint":199,"geoPoint":201,"contacts":202},"Hospital Clínico Universidad de Chile",{"type":56,"coordinates":200},[178,179],{"lat":179,"lon":178},[203],{"name":63,"role":41,"phone":11,"phoneExt":11,"email":47},{"facility":205,"status":51,"city":175,"state":11,"zip":11,"country":124,"countryCode":125,"cosmosGeoPoint":206,"geoPoint":208,"contacts":209},"Hospital del Salvador",{"type":56,"coordinates":207},[178,179],{"lat":179,"lon":178},[210],{"name":63,"role":41,"phone":11,"phoneExt":11,"email":47},{"facility":212,"status":51,"city":175,"state":11,"zip":11,"country":124,"countryCode":125,"cosmosGeoPoint":213,"geoPoint":215,"contacts":216},"Hospital El 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Goyoneche","Arequipa","Peru","PE",{"type":56,"coordinates":301},[302,303],-71.53747,-16.39899,{"lat":303,"lon":302},[306],{"name":63,"role":41,"phone":11,"phoneExt":11,"email":47},{"facility":308,"status":51,"city":297,"state":11,"zip":11,"country":298,"countryCode":299,"cosmosGeoPoint":309,"geoPoint":311,"contacts":312},"Hospital Honorio Delgado",{"type":56,"coordinates":310},[302,303],{"lat":303,"lon":302},[313],{"name":63,"role":41,"phone":11,"phoneExt":11,"email":47},{"facility":315,"status":51,"city":297,"state":11,"zip":11,"country":298,"countryCode":299,"cosmosGeoPoint":316,"geoPoint":318,"contacts":319},"Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur)",{"type":56,"coordinates":317},[302,303],{"lat":303,"lon":302},[320],{"name":63,"role":41,"phone":11,"phoneExt":11,"email":47},{"facility":322,"status":51,"city":323,"state":11,"zip":11,"country":298,"countryCode":299,"cosmosGeoPoint":324,"geoPoint":328,"contacts":329},"Clínica Monte 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Butrón","Puno",{"type":56,"coordinates":352},[353,354],-70.02198,-15.84003,{"lat":354,"lon":353},[357],{"name":63,"role":41,"phone":11,"phoneExt":11,"email":47},{"facility":359,"status":51,"city":360,"state":11,"zip":11,"country":298,"countryCode":299,"cosmosGeoPoint":361,"geoPoint":365,"contacts":366},"Instituto Regional de Enfermedades Neoplásicas del Norte (IREN Norte)","Trujillo",{"type":56,"coordinates":362},[363,364],-79.02998,-8.11599,{"lat":364,"lon":363},[367],{"name":63,"role":41,"phone":11,"phoneExt":11,"email":47},{"type":369,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[371,373,375,377,379,382,384,386,388,390,392,394,396,398,400,402,404],{"name":372,"class":6},"University Hospital Heidelberg",{"name":374,"class":6},"Universidad Austral de Chile",{"name":376,"class":6},"Universidad de La Frontera",{"name":378,"class":6},"Universidad Católica del Maule",{"name":380,"class":381},"Centre international de recherche sur le cancer (IARC, France)","UNKNOWN",{"name":383,"class":6},"University of Chile",{"name":385,"class":381},"Instituto Nacional de Enfermedades Neoplásicas (INEN, Peru)",{"name":387,"class":381},"Universidad Mayor de San Simón (UMSS, Bolivia)",{"name":389,"class":6},"Oslo University Hospital",{"name":391,"class":381},"Sanatorio el Carmen (Argentina)",{"name":393,"class":6},"Pontificia Universidad Catolica de Chile",{"name":395,"class":6},"University of Bristol",{"name":397,"class":6},"University of Oslo",{"name":399,"class":381},"Chilean institutions (See detailed study description below)",{"name":401,"class":381},"Peruvian institutions (See detailed study description below)",{"name":403,"class":381},"Bolivian institutions (See detailed study description below)",{"name":405,"class":381},"Argentinian institutions (See detailed study description below)","100530894","eulat-eradicate-gbc-100530894",false,"NCT06192719","EULAT Eradicate GBC","Establishment and Exploitation of a European-Latin American Research Consortium Towards Eradication of Preventable Gallbladder Cancer - EULAT Eradicate GBC","EULAT","Inclusion Criteria:\n\n1. Cohort A. Patients with gallbladder cancer or dysplasia, both before and after the start of their anticancer treatment.\n\n   Cohort B. Patients with cholelithiasis before cholecystectomy (only patients scheduled for cholecystectomy will be recruited)\n2. Diagnosis confirmed in accordance with standard protocols of the participating hospitals\n3. Men and women aged 18 or over\n\nExclusion Criteria:\n\n1. Any medical condition that present an unreasonable risk to the participant.\n2. Any psychiatric condition that interferes with understanding informed consent.","ALL","18 Years",{"count":417,"type":418},15000,"ESTIMATED","OBSERVATIONAL","Gallstones are relatively frequent in women and constitute one of the main risk factors for gallbladder cancer (GBC).\n\nCurrently, GBC diagnosis is mainly based on imaging (ultrasound or abdominal CT) associated with invasive examinations (biopsy and surgery), with no marker available to date to accurately predict risk and diagnose the disease early. The only curative treatment for GBC remains surgery with complete resection of tumors in early stages.\n\nGiven the aggressiveness of GBC and the very limited therapeutic options, as well as the possibility of preventing GBC by cholecystectomy during the 10 to 20 years required for the development of gallbladder tumors, it is imperative to develop effective and efficient prevention strategies based on a prioritization of interventions according to environmental and genetic-molecular risk factors.\n\nThe investigators aim to identify epidemiological factors linked to the development of GBC, and to identify, validate and functionally characterize genetic-molecular markers in blood, saliva, urine, bile and stool that allow risk prediction, early diagnosis and precision treatment of incidental tumors.",[422,423],"Gallbladder Cancer","Gallstone Disease","2026-02-16",{"date":426,"type":427},"2026-02-18","ACTUAL",{"date":429,"type":427},"2019-12-01",{"date":431,"type":418},"2028-12-31",{"name":5,"class":6},36]