EULAT Eradicate GBC

Recruiting

• Conditions: Gallbladder Cancer; Gallstone Disease
• Interventions: Other: None, observational study.

• Registration Number: NCT06192719
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

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.

Study Timeline

• Study Start: 2019-12-01
• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2023-12-21
• Study First Posted: 2024-01-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gallbladder Cancer/Dysplasia	None, observational study.	Patients affected by gallbladder cancer or dysplasia, both before and after starting their treatment
Gallstone disease	None, observational study.	Patients affected by cholelithiasis before cholecystectomy (only patients scheduled for cholecystectomy will be recruited)

Primary Outcome Measures

Name	Time	Method
Number of participants with Gallbladder Cancer/Dysplasia development	At inclusion or after pathological examination of the resected gallbladder

Trial Locations

Locations (36)

Sanatorio el Carmen; 🇦🇷 Salta, Argentina

Instituto Gastroenterológico; 🇧🇴 Cochabamba, Bolivia

Instituto Oncológico Nacional; 🇧🇴 Cochabamba, Bolivia

Hospital Regional de Arica; 🇨🇱 Arica, Chile

Hospital De Puerto Montt; 🇨🇱 Puerto Montt, Chile

Hospital Clínico Universidad de Chile; 🇨🇱 Santiago de Chile, Chile

Hospital Regional de Talca; 🇨🇱 Talca, Chile

Hospital Regional de Temuco; 🇨🇱 Temuco, Chile

Instituto Regional de Enfermedades Neoplásicas del Norte (IREN Norte); 🇵🇪 Trujillo, Peru

Hospital Obrero No. 2 (Caja Nacional del Seguro Social); 🇧🇴 Cochabamba, Bolivia

Hospital Padre Hurtado; 🇨🇱 Santiago de Chile, Chile

Hospital del Norte; 🇧🇴 Cochabamba, Bolivia

Hospital Barros Luco; 🇨🇱 Santiago de Chile, Chile

Hospital del Salvador; 🇨🇱 Santiago de Chile, Chile

Institut de cancérologie Strasbourg Europe; 🇫🇷 Strasbourg, France

Clínica Monte Sinaí; 🇵🇪 Juliaca, Peru

Hospital Papa Francisco; 🇦🇷 Salta, Argentina

Complejo Hospitalario Viedma; 🇧🇴 Cochabamba, Bolivia

Clínica Alemana de Santiago; 🇨🇱 Santiago de Chile, Chile

Fundación Arturo López Perez (FALP); 🇨🇱 Santiago de Chile, Chile

Hospital El Pino; 🇨🇱 Santiago de Chile, Chile

Hospital San Borja; 🇨🇱 Santiago de Chile, Chile

Hospital San Juan de Dios; 🇨🇱 Santiago de Chile, Chile

Hospital Goyoneche; 🇵🇪 Arequipa, Peru

Hospital Pablo Soria; 🇦🇷 Jujuy, Argentina

Hospital Regional de Concepción; 🇨🇱 Concepción, Chile

Hospital Clínico de Magallanes; 🇨🇱 Punta Arenas, Chile

Hospital Regional de Rancagua; 🇨🇱 Rancagua, Chile

Hospital Sótero del Río; 🇨🇱 Santiago de Chile, Chile

Clínica Alemana de Temuco; 🇨🇱 Temuco, Chile

Complejo Asistencial Padre Las Casas; 🇨🇱 Temuco, Chile

Hospital Honorio Delgado; 🇵🇪 Arequipa, Peru

Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur); 🇵🇪 Arequipa, Peru

Hospital Base III- La Capilla ESSALUD; 🇵🇪 Juliaca, Peru

Instituto Nacional de Enfermedades Neoplásicas (INEN); 🇵🇪 Lima, Peru

Hospital Regional Manuel Nuñez Butrón; 🇵🇪 Puno, Peru