EULAT Eradicate GBC

Gallbladder Cancer Clinical Trial

— EULAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192719
• Other study ID #: 2023-020
• Status: Recruiting
• Start date: December 1, 2019
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2023
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Dominique SCHERER, PhD
• Phone: +49 6221 56 7303
• Email: scherer[@]imbi.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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. We 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.

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. We plan to generate the information needed to establish and refine current prevention programmes, including the primary, secondary and tertiary prevention of GBC. We 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallbladder Cancer
• Gallbladder Neoplasms
• Gallstone Disease
• Gallstones

Intervention

Other:
• None, observational study.
Epidemiological, clinical and dietary data will be collected along with blood, saliva, urine, bile, feces and gallbladder tissue samples.

Locations

Country	Name	City	State
Argentina	Hospital Pablo Soria	Jujuy
Argentina	Hospital Papa Francisco	Salta
Argentina	Sanatorio el Carmen	Salta
Bolivia	Complejo Hospitalario Viedma	Cochabamba
Bolivia	Hospital del Norte	Cochabamba
Bolivia	Hospital Obrero No. 2 (Caja Nacional del Seguro Social)	Cochabamba
Bolivia	Instituto Gastroenterológico	Cochabamba
Bolivia	Instituto Oncológico Nacional	Cochabamba
Chile	Hospital Regional de Arica	Arica
Chile	Hospital Regional de Concepción	Concepción
Chile	Hospital De Puerto Montt	Puerto Montt
Chile	Hospital Clínico de Magallanes	Punta Arenas
Chile	Hospital Regional de Rancagua	Rancagua
Chile	Clínica Alemana de Santiago	Santiago de Chile
Chile	Fundación Arturo López Perez (FALP)	Santiago de Chile
Chile	Hospital Barros Luco	Santiago de Chile
Chile	Hospital Clínico Universidad de Chile	Santiago de Chile
Chile	Hospital del Salvador	Santiago de Chile
Chile	Hospital El Pino	Santiago de Chile
Chile	Hospital Padre Hurtado	Santiago de Chile
Chile	Hospital San Borja	Santiago de Chile
Chile	Hospital San Juan de Dios	Santiago de Chile
Chile	Hospital Sótero del Río	Santiago de Chile
Chile	Hospital Regional de Talca	Talca
Chile	Clínica Alemana de Temuco	Temuco
Chile	Complejo Asistencial Padre Las Casas	Temuco
Chile	Hospital Regional de Temuco	Temuco
France	Institut de cancérologie Strasbourg Europe	Strasbourg
Peru	Hospital Goyoneche	Arequipa
Peru	Hospital Honorio Delgado	Arequipa
Peru	Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur)	Arequipa
Peru	Clínica Monte Sinaí	Juliaca
Peru	Hospital Base III- La Capilla ESSALUD	Juliaca
Peru	Instituto Nacional de Enfermedades Neoplásicas (INEN)	Lima
Peru	Hospital Regional Manuel Nuñez Butrón	Puno
Peru	Instituto Regional de Enfermedades Neoplásicas del Norte (IREN Norte)	Trujillo

Sponsors (18)

Lead Sponsor

Collaborator

Institut de cancérologie Strasbourg Europe

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

Countries where clinical trial is conducted

Argentina,  Bolivia,  Chile,  France,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gallbladder Cancer/Dysplasia development		At inclusion or after pathological examination of the resected gallbladder

External Links

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