EULAT Eradicate GBC

NCT06192719 | Recruiting

• 1 other identifier: 2023-020
• Study Type: observational
• Target: 15,000
• Locations: 5 countries
• Sites: 36

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.

Conditions

Gallbladder Cancer; Gallstone Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants with Gallbladder Cancer/Dysplasia development

  At inclusion or after pathological examination of the resected gallbladder

Study Arms (2)

Gallbladder Cancer/Dysplasia

Patients affected by gallbladder cancer or dysplasia, both before and after starting their treatment

Other: None, observational study.

Gallstone disease

Patients affected by cholelithiasis before cholecystectomy (only patients scheduled for cholecystectomy will be recruited)

Other: None, observational study.

Interventions

None, observational study. OTHER

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

Gallbladder Cancer/Dysplasia; Gallstone disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants are adults with GBC, gallbladder dysplasia, or cholelithiasis.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Paul Strauss: lead
• Heidelberg University Hospital (UKHD, Germany, Coordinator): collaborator
• Universidad Austral de Chile (UACH, Chile): collaborator
• Universidad de la Frontera (UFRO, Chile): collaborator
• Universidad Católica del Maule (UCM, Chile): collaborator
• Centre international de recherche sur le cancer (IARC, France): collaborator
• Universidad de Chile (UChile, Chile): collaborator
• Instituto Nacional de Enfermedades Neoplásicas (INEN, Peru): collaborator
• Universidad Mayor de San Simón (UMSS, Bolivia): collaborator
• Oslo University Hospital: collaborator
• Sanatorio el Carmen (Argentina): collaborator
• Pontificia Universidad Católica de Chile (PUC, Chile): collaborator
• University of Bristol: collaborator
• University of Oslo: collaborator
• Chilean institutions (See detailed study description below): collaborator
• Peruvian institutions (See detailed study description below): collaborator
• Bolivian institutions (See detailed study description below): collaborator
• Argentinian institutions (See detailed study description below): collaborator

Study Sites (36)

Hospital Papa Francisco

Salta, Argentina

RECRUITING

Sanatorio el Carmen

Salta, Argentina

RECRUITING

Hospital Pablo Soria

San Salvador de Jujuy, Argentina

RECRUITING

Complejo Hospitalario Viedma

Cochabamba, Bolivia

RECRUITING

Hospital del Norte

Cochabamba, Bolivia

RECRUITING

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

Cochabamba, Bolivia

RECRUITING

Instituto Gastroenterológico

Cochabamba, Bolivia

RECRUITING

Instituto Oncológico Nacional

Cochabamba, Bolivia

RECRUITING

Hospital Regional de Arica

Arica, Chile

RECRUITING

Hospital Regional de Concepción

Concepción, Chile

RECRUITING

Hospital De Puerto Montt

Port Montt, Chile

RECRUITING

Hospital Clínico de Magallanes

Punta Arenas, Chile

RECRUITING

Hospital Regional de Rancagua

Rancagua, Chile

RECRUITING

Clínica Alemana de Santiago

Santiago, Chile

RECRUITING

Fundación Arturo López Perez (FALP)

Santiago, Chile

RECRUITING

Hospital Barros Luco

Santiago, Chile

RECRUITING

Hospital Clínico Universidad de Chile

Santiago, Chile

RECRUITING

Hospital del Salvador

Santiago, Chile

RECRUITING

Hospital El Pino

Santiago, Chile

RECRUITING

Hospital Padre Hurtado

Santiago, Chile

RECRUITING

Hospital San Borja

Santiago, Chile

RECRUITING

Hospital San Juan de Dios

Santiago, Chile

RECRUITING

Hospital Sótero del Río

Santiago, Chile

RECRUITING

Hospital Regional de Talca

Talca, Chile

RECRUITING

Clínica Alemana de Temuco

Temuco, Chile

RECRUITING

Complejo Asistencial Padre Las Casas

Temuco, Chile

RECRUITING

Hospital Regional de Temuco

Temuco, Chile

RECRUITING

Centre Paul Strauss

Strasbourg, France

RECRUITING

Hospital Goyoneche

Arequipa, Peru

RECRUITING

Hospital Honorio Delgado

Arequipa, Peru

RECRUITING

Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur)

Arequipa, Peru

RECRUITING

Clínica Monte Sinaí

Juliaca, Peru

RECRUITING

Hospital Base III- La Capilla ESSALUD

Juliaca, Peru

RECRUITING

Instituto Nacional de Enfermedades Neoplásicas (INEN)

Lima, Peru

RECRUITING

Hospital Regional Manuel Nuñez Butrón

Puno, Peru

RECRUITING

Instituto Regional de Enfermedades Neoplásicas del Norte (IREN Norte)

Trujillo, Peru

RECRUITING

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Saliva, Urina, Bile, Feaces and Gallbladder tissue. Hemoderivatives (whole blood, serum, plasma and buffy coat).

MeSH Terms

Conditions

Gallbladder Neoplasms; Cholelithiasis

Interventions

Observation

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Justo LORENZO BERMEJO, PhD

  Heidelberg University Hospital (UKHD, Germany) and Centre Paul Strauss (CPS, France)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique SCHERER, PhD

CONTACT

+49 6221 56 7303; scherer@imbi.uni-heidelberg.de

Carol BARAHONA PONCE, PhD

CONTACT

+49 6221 56 7616; barahona@imbi.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: December 1, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

BO (5); FR (1); PE (8); AR (3); CL (19)