Gallbladder Cancer Clinical Trial
— EULATOfficial title:
Establishment and Exploitation of a European-Latin American Research Consortium Towards Eradication of Preventable Gallbladder Cancer - EULAT Eradicate GBC
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.
| 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. |
| 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 |
| 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 |
Argentina, Bolivia, Chile, France, Peru,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with Gallbladder Cancer/Dysplasia development | At inclusion or after pathological examination of the resected gallbladder |
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