RecruitingNCT06192719

EULAT Eradicate GBC

Establishment and Exploitation of a European-Latin American Research Consortium Towards Eradication of Preventable Gallbladder Cancer - EULAT Eradicate GBC


Sponsor

Centre Paul Strauss

Enrollment

15,000 participants

Start Date

Dec 1, 2019

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria2

  • Any medical condition that present an unreasonable risk to the participant.
  • Any psychiatric condition that interferes with understanding informed consent.

Interventions

OTHERNone, observational study.

Epidemiological, clinical and dietary data will be collected along with blood, saliva, urine, bile, feces and gallbladder tissue samples.


Locations(36)

Hospital Papa Francisco

Salta, Argentina

Sanatorio el Carmen

Salta, Argentina

Hospital Pablo Soria

San Salvador de Jujuy, Argentina

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, Bolivia

Hospital Regional de Arica

Arica, Chile

Hospital Regional de Concepción

Concepción, Chile

Hospital De Puerto Montt

Port Montt, Chile

Hospital Clínico de Magallanes

Punta Arenas, Chile

Hospital Regional de Rancagua

Rancagua, Chile

Clínica Alemana de Santiago

Santiago, Chile

Fundación Arturo López Perez (FALP)

Santiago, Chile

Hospital Barros Luco

Santiago, Chile

Hospital Clínico Universidad de Chile

Santiago, Chile

Hospital del Salvador

Santiago, Chile

Hospital El Pino

Santiago, Chile

Hospital Padre Hurtado

Santiago, Chile

Hospital San Borja

Santiago, Chile

Hospital San Juan de Dios

Santiago, Chile

Hospital Sótero del Río

Santiago, 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, Chile

Centre Paul Strauss

Strasbourg, France

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, Peru

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NCT06192719


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