- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06192719
EULAT Eradicate GBC (EULAT)
Establishment and Exploitation of a European-Latin American Research Consortium Towards Eradication of Preventable Gallbladder Cancer - EULAT Eradicate GBC
Gallstones are relatively frequent in women and constitute one of the main risk factors for gallbladder cancer (GBC).
Currently, 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.
Given 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.
The 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
The 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dominique SCHERER, PhD
- Phone Number: +49 6221 56 7303
- Email: scherer@imbi.uni-heidelberg.de
Study Contact Backup
- Name: Carol BARAHONA PONCE, PhD
- Phone Number: +49 6221 56 7616
- Email: barahona@imbi.uni-heidelberg.de
Study Locations
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Jujuy, Argentina
- Recruiting
- Hospital Pablo Soria
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Salta, Argentina
- Recruiting
- Hospital Papa Francisco
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Salta, Argentina
- Recruiting
- Sanatorio el Carmen
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Cochabamba, Bolivia
- Recruiting
- Complejo Hospitalario Viedma
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Cochabamba, Bolivia
- Recruiting
- Hospital del Norte
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Cochabamba, Bolivia
- Recruiting
- Hospital Obrero No. 2 (Caja Nacional del Seguro Social)
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Cochabamba, Bolivia
- Recruiting
- Instituto Gastroenterológico
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Cochabamba, Bolivia
- Recruiting
- Instituto Oncológico Nacional
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Arica, Chile
- Recruiting
- Hospital Regional de Arica
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Concepción, Chile
- Recruiting
- Hospital Regional de Concepción
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Puerto Montt, Chile
- Recruiting
- Hospital De Puerto Montt
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Punta Arenas, Chile
- Recruiting
- Hospital Clínico de Magallanes
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Rancagua, Chile
- Recruiting
- Hospital Regional de Rancagua
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Santiago de Chile, Chile
- Recruiting
- Clinica Alemana de Santiago
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Santiago de Chile, Chile
- Recruiting
- Fundación Arturo López Perez (FALP)
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Santiago de Chile, Chile
- Recruiting
- Hospital Barros Luco
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Santiago de Chile, Chile
- Recruiting
- Hospital Clinico Universidad de Chile
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Santiago de Chile, Chile
- Recruiting
- Hospital del Salvador
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Santiago de Chile, Chile
- Recruiting
- Hospital El Pino
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Santiago de Chile, Chile
- Recruiting
- Hospital Padre Hurtado
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Santiago de Chile, Chile
- Recruiting
- Hospital San Borja
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Santiago de Chile, Chile
- Recruiting
- Hospital San Juan de Dios
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Santiago de Chile, Chile
- Recruiting
- Hospital Sotero del Rio
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Talca, Chile
- Recruiting
- Hospital Regional de Talca
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Temuco, Chile
- Recruiting
- Clínica Alemana de Temuco
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Temuco, Chile
- Recruiting
- Complejo Asistencial Padre Las Casas
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Temuco, Chile
- Recruiting
- Hospital Regional de Temuco
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Strasbourg, France
- Recruiting
- Institut de Cancérologie Strasbourg Europe
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Principal Investigator:
- Meher BEN ABDELGHANI, MD
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Contact:
- Manon VOEGELIN
- Email: promotion-rc@icans.eu
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Arequipa, Peru
- Recruiting
- Hospital Goyoneche
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Arequipa, Peru
- Recruiting
- Hospital Honorio Delgado
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Arequipa, Peru
- Recruiting
- Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur)
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Juliaca, Peru
- Recruiting
- Clínica Monte Sinaí
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Juliaca, Peru
- Recruiting
- Hospital Base III- La Capilla ESSALUD
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Lima, Peru
- Recruiting
- Instituto Nacional de Enfermedades Neoplasicas (INEN)
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Puno, Peru
- Recruiting
- Hospital Regional Manuel Nuñez Butrón
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Trujillo, Peru
- Recruiting
- Instituto Regional de Enfermedades Neoplásicas del Norte (IREN Norte)
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Contact:
- Carol Barahona Ponce, PhD
- Email: barahona@imbi.uni-heidelberg.de
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Cohort A. Patients with gallbladder cancer or dysplasia, both before and after the start of their anticancer treatment.
Cohort B. Patients with cholelithiasis before cholecystectomy (only patients scheduled for cholecystectomy will be recruited)
- Diagnosis confirmed in accordance with standard protocols of the participating hospitals
- Men and women aged 18 or over
Exclusion Criteria:
- Any medical condition that present an unreasonable risk to the participant.
- Any psychiatric condition that interferes with understanding informed consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Gallbladder Cancer/Dysplasia
Patients affected by gallbladder cancer or dysplasia, both before and after starting their treatment
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Epidemiological, clinical and dietary data will be collected along with blood, saliva, urine, bile, feces and gallbladder tissue samples.
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Gallstone disease
Patients affected by cholelithiasis before cholecystectomy (only patients scheduled for cholecystectomy will be recruited)
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Epidemiological, clinical and dietary data will be collected along with blood, saliva, urine, bile, feces and gallbladder tissue samples.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with Gallbladder Cancer/Dysplasia development
Time Frame: At inclusion or after pathological examination of the resected gallbladder
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At inclusion or after pathological examination of the resected gallbladder
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Justo LORENZO BERMEJO, PhD, Heidelberg University Hospital (UKHD, Germany) and Institut de cancérologie Strasbourg Europe (ICANS, France)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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