Gallbladder CancerEULATNCT06192719
EULAT Eradicate GBC
An observational study of Gallbladder Cancer and Gallstone Disease, run by Centre Paul Strauss at 36 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallbladder Cancer, Gallstone Disease
- What is being tested?
- None, observational study.
- How many people
- 15,000 participants
- Where
- 36 sitesin 5 countries
- Study dates
- 1 Dec 2019to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are adults with GBC, gallbladder dysplasia, or cholelithiasis.
Who may be able to join
- 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
Who cannot join
- Any medical condition that present an unreasonable risk to the participant.
- Any psychiatric condition that interferes with understanding informed consent.
Trial locations and contacts
36 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
36 sites in 5 countries
Chile19 sites, 19 recruiting
- Recruiting
Hospital Regional de Arica
Arica
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital Regional de Concepción
Concepción
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital De Puerto Montt
Port Montt
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital Clínico de Magallanes
Punta Arenas
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital Regional de Rancagua
Rancagua
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Clínica Alemana de Santiago
Santiago
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Fundación Arturo López Perez (FALP)
Santiago
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital Barros Luco
Santiago
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital Clínico Universidad de Chile
Santiago
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital del Salvador
Santiago
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital El Pino
Santiago
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital Padre Hurtado
Santiago
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital San Borja
Santiago
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital San Juan de Dios
Santiago
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital Sótero del Río
Santiago
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital Regional de Talca
Talca
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Clínica Alemana de Temuco
Temuco
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Complejo Asistencial Padre Las Casas
Temuco
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital Regional de Temuco
Temuco
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
Peru8 sites, 8 recruiting
- Recruiting
Hospital Goyoneche
Arequipa
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital Honorio Delgado
Arequipa
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur)
Arequipa
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Clínica Monte Sinaí
Juliaca
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital Base III- La Capilla ESSALUD
Juliaca
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Instituto Nacional de Enfermedades Neoplásicas (INEN)
Lima
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital Regional Manuel Nuñez Butrón
Puno
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Instituto Regional de Enfermedades Neoplásicas del Norte (IREN Norte)
Trujillo
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
Bolivia5 sites, 5 recruiting
- Recruiting
Complejo Hospitalario Viedma
Cochabamba
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital del Norte
Cochabamba
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital Obrero No. 2 (Caja Nacional del Seguro Social)
Cochabamba
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Instituto Gastroenterológico
Cochabamba
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Instituto Oncológico Nacional
Cochabamba
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
Argentina3 sites, 3 recruiting
- Recruiting
Hospital Papa Francisco
Salta
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Sanatorio el Carmen
Salta
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
- Recruiting
Hospital Pablo Soria
San Salvador de Jujuy
Carol Barahona Ponce, PhD, barahona@imbi.uni-heidelberg.de
France1 site, 1 recruiting
- Recruiting
Centre Paul Strauss
Strasbourg
Manon VOEGELIN, promotion-rc@icans.eu
Meher BEN ABDELGHANI, MD
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Gallbladder Cancer, Gallstone Disease
- Being tested
- None, observational study.
- Medical subject headings
- Gallbladder Neoplasms, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, observational study.Other
Epidemiological, clinical and dietary data will be collected along with blood, saliva, urine, bile, feces and gallbladder tissue samples.
| Study group | Role | What they receive |
|---|---|---|
| Gallbladder Cancer/Dysplasia | Patients affected by gallbladder cancer or dysplasia, both before and after starting their treatment Receives: Other: None, observational study. | |
| Gallstone disease | Patients affected by cholelithiasis before cholecystectomy (only patients scheduled for cholecystectomy will be recruited) Receives: Other: None, observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Gallbladder Cancer/Dysplasia development
Measured: At inclusion or after pathological examination of the resected gallbladder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Dec 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg, Universidad Austral de Chile, Universidad de La Frontera, Universidad Católica del Maule, Centre international de recherche sur le cancer (IARC, France), University of Chile, Instituto Nacional de Enfermedades Neoplásicas (INEN, Peru), Universidad Mayor de San Simón (UMSS, Bolivia), Oslo University Hospital, Sanatorio el Carmen (Argentina), Pontificia Universidad Catolica de 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)
- Responsible party
- Sponsor
- Investigators
- Justo LORENZO BERMEJO, PhD, Principal investigator, Heidelberg University Hospital (UKHD, Germany) and Centre Paul Strauss (CPS, France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192719
- Sponsor's protocol ID
- 2023-020
- Acronym
- EULAT
- Status last verified
- Feb 2026
- First submitted
- 21 Dec 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Exploitation of a European-Latin American Research Consortium Towards Eradication of Preventable Gallbladder Cancer - EULAT Eradicate GBC
- ClinicalTrials.gov ID
- NCT06192719
- Acronym / sponsor ID
- EULAT / 2023-020
- Conditions
- Gallbladder Cancer, Gallstone Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg, Universidad Austral de Chile, Universidad de La Frontera, Universidad Católica del Maule, Centre international de recherche sur le cancer (IARC, France), University of Chile, Instituto Nacional de Enfermedades Neoplásicas (INEN, Peru), Universidad Mayor de San Simón (UMSS, Bolivia), Oslo University Hospital, Sanatorio el Carmen (Argentina), Pontificia Universidad Catolica de 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)
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gallbladder Cancer/Dysplasia | – | Other: None, observational study.Patients affected by gallbladder cancer or dysplasia, both before and after starting their treatment |
| Gallstone disease | – | Other: None, observational study.Patients affected by cholelithiasis before cholecystectomy (only patients scheduled for cholecystectomy will be recruited) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are adults with GBC, gallbladder dysplasia, or cholelithiasis.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Any medical condition that present an unreasonable risk to the participant.
- Any psychiatric condition that interferes with understanding informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None, observational study.Epidemiological, clinical and dietary data will be collected along with blood, saliva, urine, bile, feces and gallbladder tissue samples. | Other | Gallbladder Cancer/Dysplasia, Gallstone disease |
Primary outcome
Number of participants with Gallbladder Cancer/Dysplasia development
Time frame: At inclusion or after pathological examination of the resected gallbladder
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justo LORENZO BERMEJO, PhD principal investigator
Heidelberg University Hospital (UKHD, Germany) and Centre Paul Strauss (CPS, France)
36 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallbladder Cancer and Gallstone Disease, run by Centre Paul Strauss at 36 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Chile, Peru, Bolivia, Argentina, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominique SCHERER, PhD (+49 6221 56 7303, scherer@imbi.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Gallbladder Cancer/Dysplasia development (time frame: At inclusion or after pathological examination of the resected gallbladder). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.