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EULAT Eradicate GBC

EULAT Eradicate GBC

NCT ID: NCT06192719

Last Updated: 2026-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gallbladder Cancer Gallstone Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Gallbladder Cancer/Dysplasia

Patients affected by gallbladder cancer or dysplasia, both before and after starting their treatment

None, observational study.

Intervention Type OTHER

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

Gallstone disease

Patients affected by cholelithiasis before cholecystectomy (only patients scheduled for cholecystectomy will be recruited)

None, observational study.

Intervention Type OTHER

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

Interventions

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None, observational study.

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justo LORENZO BERMEJO, PhD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University Hospital (UKHD, Germany) and Institut de cancérologie Strasbourg Europe (ICANS, France)

Trujillo, , Peru

Site Status RECRUITING

Countries

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Argentina Bolivia Chile France Peru

Central Contacts

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Dominique SCHERER, PhD

Role: CONTACT

[email protected]

+49 6221 56 7303

Carol BARAHONA PONCE, PhD

Role: CONTACT

[email protected]

+49 6221 56 7616

Role: primary

[email protected]

Other Identifiers

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2023-020

Identifier Type: -

Identifier Source: org_study_id

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EULAT Eradicate GBC

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Chile Biliary Longitudinal Study

Validation of a Score That Predicts Residual Disease in Incidental Gallbladder Cancer

Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution

Indications for Gallbladder Surgery in Gallstone Disease

Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage

Detailed Description

Conditions

Study Design

Study Groups

Gallbladder Cancer/Dysplasia

None, observational study.

Gallstone disease

None, observational study.

Interventions

None, observational study.

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Heidelberg University Hospital (UKHD, Germany, Coordinator)

Universidad Austral de Chile (UACH, Chile)

Universidad de la Frontera (UFRO, Chile)

Universidad Católica del Maule (UCM, Chile)

Centre international de recherche sur le cancer (IARC, France)

Universidad de Chile (UChile, Chile)

Instituto Nacional de Enfermedades Neoplásicas (INEN, Peru)

Universidad Mayor de San Simón (UMSS, Bolivia)

Oslo University Hospital

Sanatorio el Carmen (Argentina)

Pontificia Universidad Católica de Chile (PUC, Chile)

University of Bristol

University of Oslo

Chilean institutions (See detailed study description below)

Peruvian institutions (See detailed study description below)

Bolivian institutions (See detailed study description below)

Argentinian institutions (See detailed study description below)

Centre Paul Strauss

Responsible Party

Principal Investigators

Justo LORENZO BERMEJO, PhD

Locations

Hospital Papa Francisco

Sanatorio el Carmen

Hospital Pablo Soria

Complejo Hospitalario Viedma

Hospital del Norte

Hospital Obrero No. 2 (Caja Nacional del Seguro Social)

Instituto Gastroenterológico

Instituto Oncológico Nacional

Hospital Regional de Arica

Hospital Regional de Concepción

Hospital De Puerto Montt

Hospital Clínico de Magallanes

Hospital Regional de Rancagua

Clínica Alemana de Santiago

Fundación Arturo López Perez (FALP)

Hospital Barros Luco

Hospital Clínico Universidad de Chile

Hospital del Salvador

Hospital El Pino

Hospital Padre Hurtado

Hospital San Borja

Hospital San Juan de Dios

Hospital Sótero del Río

Hospital Regional de Talca

Clínica Alemana de Temuco

Complejo Asistencial Padre Las Casas

Hospital Regional de Temuco

Institut de cancérologie Strasbourg Europe

Hospital Goyoneche

Hospital Honorio Delgado

Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur)

Clínica Monte Sinaí

Hospital Base III- La Capilla ESSALUD

Instituto Nacional de Enfermedades Neoplásicas (INEN)