An observational study in Gallbladder Cancer and Gallstone Disease, sponsored by Centre Paul Strauss. Recruiting at 36 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Centre Paul Strauss · Observational
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.
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.
301 studies on the registry are indexed under Gallbladder Neoplasms; 65 are open to participants now.
This study's planned enrollment of 15,000 is above the median of 200 across 61 observational studies indexed under Gallbladder Neoplasms.
Browse Gallbladder Neoplasms studies →Centre Paul Strauss is the lead sponsor of 31 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants are adults with GBC, gallbladder dysplasia, or cholelithiasis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients affected by gallbladder cancer or dysplasia, both before and after starting their treatment
Other: None, observational study.
Patients affected by cholelithiasis before cholecystectomy (only patients scheduled for cholecystectomy will be recruited)
Other: None, observational study.
Epidemiological, clinical and dietary data will be collected along with blood, saliva, urine, bile, feces and gallbladder tissue samples.
Number of participants with Gallbladder Cancer/Dysplasia development
Time frame: At inclusion or after pathological examination of the resected gallbladder
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Paul Strauss