Validation of Differential Serum Levels for Five Minerals in South American Gallstone Patients With and Without Gallbladder Cancer
METALS
Validation of the Association Between the Abundance of Three Bacterial Genera in Stool Samples and the Risk of Gallbladder Cancer in South American Patients With Gallstones
1 other identifier
observational
230
4 countries
33
Brief Summary
We have previously observed that serum concentrations of five minerals - aluminium, copper, sulphur, zinc, and bromine - differ between South American patients with gallbladder cancer and those with gallstones. The aim of this study is to confirm these differences using an independent set of serum samples from South American patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2019
Longer than P75 for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedFirst Submitted
Initial submission to the registry
June 8, 2026
CompletedFirst Posted
Study publicly available on registry
June 11, 2026
CompletedJune 11, 2026
June 1, 2026
6.2 years
June 8, 2026
June 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Serum concentrations of five minerals among South American gallstone patients with and without gallbladder cancer
Baseline
Study Arms (2)
South American patients with gallbladder cancer
South American patients with gallstones
with no evidence of gallbladder cancer upon pathological examination of the gallbladder after cholecistectomy
Interventions
Pathological examination of the gallbladder after cholecystectomy
Eligibility Criteria
Patients with gallstones and cancer-free OR - Patients with gallbladder cancer
You may qualify if:
- Patients with gallstones and cancer-free OR - Patients with gallbladder cancer
You may not qualify if:
- Patients younger than 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
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 Clínico de Magallanes
Arica, Chile
Hospital Regional de Arica
Arica, Chile
Hospital Regional de Concepción
Concepción, Chile
Hospital De Puerto Montt
Port Montt, 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
Statistical Genetics Research Group, Institute of Medical Biometry, University of Heidelberg
Heidelberg, Germany
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
Related Links
Biospecimen
Serum samples will be digested and analysed by inductively coupled plasma mass spectrometry (ICP-MS) on an Agilent 7850 instrument, using indium (In) as an internal standard for signal normalization. More than 50 minerals and metals will be quantified per sample. Based on preliminary data, it is expected that approximately 30 analytes will pass all quality filters and be retained for statistical analysis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2026
First Posted
June 11, 2026
Study Start
December 1, 2019
Primary Completion
January 31, 2026
Study Completion
January 31, 2026
Last Updated
June 11, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Access Criteria
- Upon request
Unidentifiable patient data will be deposited in a public data repository after publication, data accession numbers will be provided in the article and upon request.