EULAT Eradicate GBC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: None, observational study..
- Who it may be relevant to
- Registry conditions: Gallbladder Cancer, Gallstone Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina, Bolivia, Chile, France, Peru
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Establishment and Exploitation of a European-Latin American Research Consortium Towards Eradication of Preventable Gallbladder Cancer - EULAT Eradicate GBC
Overview
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.
Interventions
- Other None, observational study.
Epidemiological, clinical and dietary data will be collected along with blood, saliva, urine, bile, feces and gallbladder tissue samples.
Primary outcome measures
- Number of participants with Gallbladder Cancer/Dysplasia development [Time frame: At inclusion or after pathological examination of the resected gallbladder]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Any medical condition that present an unreasonable risk to the participant.
- Any psychiatric condition that interferes with understanding informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Chile · 19 centers
- Hospital Regional de Arica — Arica
- Hospital Regional de Concepción — Concepción
- Hospital De Puerto Montt — Port Montt
- Hospital Clínico de Magallanes — Punta Arenas
- Hospital Regional de Rancagua — Rancagua
- Clínica Alemana de Santiago — Santiago
- Fundación Arturo López Perez (FALP) — Santiago
- Hospital Barros Luco — Santiago
- … and 11 more centers
Peru · 8 centers
- Hospital Goyoneche — Arequipa
- Hospital Honorio Delgado — Arequipa
- Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur) — Arequipa
- Clínica Monte Sinaí — Juliaca
- Hospital Base III- La Capilla ESSALUD — Juliaca
- Instituto Nacional de Enfermedades Neoplásicas (INEN) — Lima
- Hospital Regional Manuel Nuñez Butrón — Puno
- Instituto Regional de Enfermedades Neoplásicas del Norte (IREN Norte) — Trujillo
Bolivia · 5 centers
- Complejo Hospitalario Viedma — Cochabamba
- Hospital del Norte — Cochabamba
- Hospital Obrero No. 2 (Caja Nacional del Seguro Social) — Cochabamba
- Instituto Gastroenterológico — Cochabamba
- Instituto Oncológico Nacional — Cochabamba
Argentina · 3 centers
- Hospital Papa Francisco — Salta
- Sanatorio el Carmen — Salta
- Hospital Pablo Soria — San Salvador de Jujuy
France · 1 center
- Centre Paul Strauss — Strasbourg
Identifiers
NCT: NCT06192719 · 2023-020