EULAT Eradicate GBC

Last updated: May 30, 2024
Sponsor: Institut de cancérologie Strasbourg Europe
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Disorders

Liver Disorders

Biliary Tract Cancer

Treatment

None, observational study.

Clinical Study ID

NCT06192719
2023-020
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Cohort A. Patients with gallbladder cancer or dysplasia, both before and after thestart of their anticancer treatment. Cohort B. Patients with cholelithiasis before cholecystectomy (only patientsscheduled for cholecystectomy will be recruited)

  2. Diagnosis confirmed in accordance with standard protocols of the participatinghospitals

  3. Men and women aged 18 or over

Exclusion

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

Total Participants: 15000
Treatment Group(s): 1
Primary Treatment: None, observational study.
Phase:
Study Start date:
December 01, 2019
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Hospital Pablo Soria

    Jujuy,
    Argentina

    Active - Recruiting

  • Hospital Papa Francisco

    Salta,
    Argentina

    Active - Recruiting

  • Sanatorio el Carmen

    Salta,
    Argentina

    Active - Recruiting

  • Complejo Hospitalario Viedma

    Cochabamba,
    Bolivia

    Active - Recruiting

  • Hospital Obrero No. 2 (Caja Nacional del Seguro Social)

    Cochabamba,
    Bolivia

    Active - Recruiting

  • Hospital del Norte

    Cochabamba,
    Bolivia

    Active - Recruiting

  • Instituto Gastroenterológico

    Cochabamba,
    Bolivia

    Active - Recruiting

  • Instituto Oncológico Nacional

    Cochabamba,
    Bolivia

    Active - Recruiting

  • Hospital Regional de Arica

    Arica,
    Chile

    Active - Recruiting

  • Hospital Regional de Concepción

    Concepción,
    Chile

    Active - Recruiting

  • Hospital De Puerto Montt

    Puerto Montt,
    Chile

    Active - Recruiting

  • Hospital Clínico de Magallanes

    Punta Arenas,
    Chile

    Active - Recruiting

  • Hospital Regional de Rancagua

    Rancagua,
    Chile

    Active - Recruiting

  • Clínica Alemana de Santiago

    Santiago de Chile,
    Chile

    Active - Recruiting

  • Fundación Arturo López Perez (FALP)

    Santiago de Chile,
    Chile

    Active - Recruiting

  • Hospital Barros Luco

    Santiago de Chile,
    Chile

    Active - Recruiting

  • Hospital Clínico Universidad de Chile

    Santiago de Chile,
    Chile

    Active - Recruiting

  • Hospital El Pino

    Santiago de Chile,
    Chile

    Active - Recruiting

  • Hospital Padre Hurtado

    Santiago de Chile,
    Chile

    Active - Recruiting

  • Hospital San Borja

    Santiago de Chile,
    Chile

    Active - Recruiting

  • Hospital San Juan de Dios

    Santiago de Chile,
    Chile

    Active - Recruiting

  • Hospital Sótero del Río

    Santiago de Chile,
    Chile

    Active - Recruiting

  • Hospital del Salvador

    Santiago de Chile,
    Chile

    Active - Recruiting

  • Hospital Regional de Talca

    Talca,
    Chile

    Active - Recruiting

  • Clínica Alemana de Temuco

    Temuco,
    Chile

    Active - Recruiting

  • Complejo Asistencial Padre Las Casas

    Temuco,
    Chile

    Active - Recruiting

  • Hospital Regional de Temuco

    Temuco,
    Chile

    Active - Recruiting

  • Institut de cancérologie Strasbourg Europe

    Strasbourg,
    France

    Active - Recruiting

  • Hospital Goyoneche

    Arequipa,
    Peru

    Active - Recruiting

  • Hospital Honorio Delgado

    Arequipa,
    Peru

    Active - Recruiting

  • Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur)

    Arequipa,
    Peru

    Active - Recruiting

  • Clínica Monte Sinaí

    Juliaca,
    Peru

    Active - Recruiting

  • Hospital Base III- La Capilla ESSALUD

    Juliaca,
    Peru

    Active - Recruiting

  • Instituto Nacional de Enfermedades Neoplásicas (INEN)

    Lima,
    Peru

    Active - Recruiting

  • Hospital Regional Manuel Nuñez Butrón

    Puno,
    Peru

    Active - Recruiting

  • Instituto Regional de Enfermedades Neoplásicas del Norte (IREN Norte)

    Trujillo,
    Peru

    Active - Recruiting

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