EULAT Eradicate GBC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Paul Strauss
About this trial
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
This trial does not accept healthy volunteersQualifiers
Cohort A. Patients with gallbladder cancer or dysplasia, both before and after the start of their anticancer treatment.
Diagnosis confirmed in accordance with standard protocols of the participating hospitals
Men and women aged 18 or over
Disqualifiers
Any medical condition that present an unreasonable risk to the participant.
Any psychiatric condition that interferes with understanding informed consent.
Trial population
Participants are adults with GBC, gallbladder dysplasia, or cholelithiasis.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
None, observational study.
Other interventionEpidemiological, clinical and dietary data will be collected along with blood, saliva, urine, bile, feces and gallbladder tissue samples.
Treatment groups
15,000 Participants
are divided into 2 treatment groupsGroup A: Gallbladder Cancer/Dysplasia1 intervention
Group B: Gallstone disease1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with Gallbladder Cancer/Dysplasia development
Time frame
At inclusion or after pathological examination of the resected gallbladderSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Paul Strauss
Lead sponsor
University Hospital Heidelberg
Collaborator
Universidad Austral de Chile
Collaborator
Universidad de La Frontera
Collaborator
Universidad Católica del Maule
Collaborator
Centre international de recherche sur le cancer (IARC, France)
Collaborator
University of 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 Catolica de 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
Source ClinicalTrials.gov