Clinical trial NCT06192719: EULAT Eradicate GBC
Official title: Establishment and Exploitation of a European-Latin American Research Consortium Towards Eradication of Preventable Gallbladder Cancer - EULAT Eradicate GBC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gallbladder Cancer
Gallstone Disease
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
Collaborators: name: Heidelberg University Hospital (UKHD, Germany, Coordinator)
name: Universidad Austral de Chile (UACH, Chile)
name: Universidad de la Frontera (UFRO, Chile)
name: Universidad Católica del Maule (UCM, Chile)
name: Centre international de recherche sur le cancer (IARC, France)
name: Universidad de Chile (UChile, Chile)
name: Instituto Nacional de Enfermedades Neoplásicas (INEN, Peru)
name: Universidad Mayor de San Simón (UMSS, Bolivia)
name: Oslo University Hospital
name: Sanatorio el Carmen (Argentina)
name: Pontificia Universidad Católica de Chile (PUC, Chile)
name: University of Bristol
name: University of Oslo
name: Chilean institutions (See detailed study description below)
name: Peruvian institutions (See detailed study description below)
name: Bolivian institutions (See detailed study description below)
name: Argentinian institutions (See detailed study description below)
First posted: 2024-01-05
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants are adults with GBC, gallbladder dysplasia, or cholelithiasis.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with Gallbladder Cancer/Dysplasia development
timeFrame: At inclusion or after pathological examination of the resected gallbladder
Secondary outcomes:
Other outcomes:
Locations:
city: Jujuy
country: Argentina
facility: Hospital Pablo Soria
city: Salta
country: Argentina
facility: Hospital Papa Francisco
city: Salta
country: Argentina
facility: Sanatorio el Carmen
city: Cochabamba
country: Bolivia
facility: Complejo Hospitalario Viedma
city: Cochabamba
country: Bolivia
facility: Hospital del Norte
city: Cochabamba
country: Bolivia
facility: Hospital Obrero No. 2 (Caja Nacional del Seguro Social)
city: Cochabamba
country: Bolivia
facility: Instituto Gastroenterológico
city: Cochabamba
country: Bolivia
facility: Instituto Oncológico Nacional
city: Arica
country: Chile
facility: Hospital Regional de Arica
city: Concepción
country: Chile
facility: Hospital Regional de Concepción
city: Puerto Montt
country: Chile
facility: Hospital De Puerto Montt
city: Punta Arenas
country: Chile
facility: Hospital Clínico de Magallanes
city: Rancagua
country: Chile
facility: Hospital Regional de Rancagua
city: Santiago de Chile
country: Chile
facility: Clínica Alemana de Santiago
city: Santiago de Chile
country: Chile
facility: Fundación Arturo López Perez (FALP)
city: Santiago de Chile
country: Chile
facility: Hospital Barros Luco
city: Santiago de Chile
country: Chile
facility: Hospital Clínico Universidad de Chile
city: Santiago de Chile
country: Chile
facility: Hospital del Salvador
city: Santiago de Chile
country: Chile
facility: Hospital El Pino
city: Santiago de Chile
country: Chile
facility: Hospital Padre Hurtado
city: Santiago de Chile
country: Chile
facility: Hospital San Borja
city: Santiago de Chile
country: Chile
facility: Hospital San Juan de Dios
city: Santiago de Chile
country: Chile
facility: Hospital Sótero del Río
city: Talca
country: Chile
facility: Hospital Regional de Talca
city: Temuco
country: Chile
facility: Clínica Alemana de Temuco
city: Temuco
country: Chile
facility: Complejo Asistencial Padre Las Casas
city: Temuco
country: Chile
facility: Hospital Regional de Temuco
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
city: Arequipa
country: Peru
facility: Hospital Goyoneche
city: Arequipa
country: Peru
facility: Hospital Honorio Delgado
city: Arequipa
country: Peru
facility: Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur)
city: Juliaca
country: Peru
facility: Clínica Monte Sinaí
city: Juliaca
country: Peru
facility: Hospital Base III- La Capilla ESSALUD
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplásicas (INEN)
city: Puno
country: Peru
facility: Hospital Regional Manuel Nuñez Butrón
city: Trujillo
country: Peru
facility: Instituto Regional de Enfermedades Neoplásicas del Norte (IREN Norte)
Study officials:
affiliation: Heidelberg University Hospital (UKHD, Germany) and Institut de cancérologie Strasbourg Europe (ICANS, France)
name: Justo LORENZO BERMEJO, PhD
role: PRINCIPAL_INVESTIGATOR
References: