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EULAT Eradicate GBC

Establishment and Exploitation of a European-Latin American Research Consortium Towards Eradication of Preventable Gallbladder Cancer - EULAT Eradicate GBC

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06192719
Acronym
EULAT
Enrollment
15000
Registered
2024-01-05
Start date
2019-12-01
Completion date
2028-12-31
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gallbladder Cancer, Gallstone Disease

Brief summary

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.

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.

Interventions

Epidemiological, clinical and dietary data will be collected along with blood, saliva, urine, bile, feces and gallbladder tissue samples.

Sponsors

Centre Paul Strauss
Lead SponsorOTHER
Heidelberg University Hospital (UKHD, Germany, Coordinator)
CollaboratorUNKNOWN
Universidad Austral de Chile (UACH, Chile)
CollaboratorUNKNOWN
Universidad de la Frontera (UFRO, Chile)
CollaboratorUNKNOWN
Universidad Católica del Maule (UCM, Chile)
CollaboratorUNKNOWN
Centre international de recherche sur le cancer (IARC, France)
CollaboratorUNKNOWN
Universidad de Chile (UChile, Chile)
CollaboratorUNKNOWN
Instituto Nacional de Enfermedades Neoplásicas (INEN, Peru)
CollaboratorUNKNOWN
Universidad Mayor de San Simón (UMSS, Bolivia)
CollaboratorUNKNOWN
Oslo University Hospital
CollaboratorOTHER
Sanatorio el Carmen (Argentina)
CollaboratorUNKNOWN
Pontificia Universidad Católica de Chile (PUC, Chile)
CollaboratorUNKNOWN
University of Bristol
CollaboratorOTHER
University of Oslo
CollaboratorOTHER
Chilean institutions (See detailed study description below)
CollaboratorUNKNOWN
Peruvian institutions (See detailed study description below)
CollaboratorUNKNOWN
Bolivian institutions (See detailed study description below)
CollaboratorUNKNOWN
Argentinian institutions (See detailed study description below)
CollaboratorUNKNOWN

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 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) 2. Diagnosis confirmed in accordance with standard protocols of the participating hospitals 3. Men and women aged 18 or over

Exclusion criteria

1. Any medical condition that present an unreasonable risk to the participant. 2. Any psychiatric condition that interferes with understanding informed consent.

Design outcomes

Primary

MeasureTime frame
Number of participants with Gallbladder Cancer/Dysplasia developmentAt inclusion or after pathological examination of the resected gallbladder

Countries

Argentina, Bolivia, Chile, France, Peru

Contacts

CONTACTDominique SCHERER, PhD
scherer@imbi.uni-heidelberg.de+49 6221 56 7303
CONTACTCarol BARAHONA PONCE, PhD
barahona@imbi.uni-heidelberg.de+49 6221 56 7616
PRINCIPAL_INVESTIGATORJusto LORENZO BERMEJO, PhD

Heidelberg University Hospital (UKHD, Germany) and Centre Paul Strauss (CPS, France)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026