Validation of Differential Serum Levels for Five Minerals in South American Gallstone Patients With and Without Gallbladder Cancer (METALS)

June 8, 2026 updated by: Centre Paul Strauss

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gallbladder cancer (GBC) is a highly lethal malignant tumour characterised by a low global incidence, but with a disproportionately high prevalence among indigenous populations in the Americas. The absence of specific symptoms and validated early detection tools often leads to late diagnosis and poor prognosis. To date, no biomarkers have been established for the early detection of GBC.

Minerals and metals play a fundamental role in a wide range of biological processes, and both their excess and deficiency - in the wrong compartment or at the wrong time - can disrupt internal homeostatic balance. It has been proposed that such dysregulation is a relevant factor in carcinogenesis, operating through mechanisms including oxidative stress, DNA damage, and immune dysregulation. Although altered mineral profiles have been described in GBC, and several elements have been proposed as potential risk biomarkers, these findings remain largely exploratory and lack consistent validation in independent cohorts, particularly in populations with a high incidence of GBC.

In our previous research, we quantified the serum concentrations of more than 50 metals and minerals in 240 South American patients (120 with GBC and 120 with gallstones) from the EULAT Eradicate GBC study, of whom more than 30 met strict quality control criteria (e.g., concentrations above the lower limit of detection in at least 95% of samples). We observed that serum concentrations of aluminium (Al) and copper (Cu) were elevated, whilst those of sulphur (S), zinc (Zn) and bromine (Br) were reduced, in serum samples from patients with GBC compared with patients with gallstones.

The aim of this study is to validate the differences in the concentrations of these five minerals using an independent set of South American serum samples (n=115 patients with GBC and n=115 patients with gallstones).

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.

Metal concentration data will be analysed using R. Overall mineral/metal profiles will be assessed through principal component analysis to identify samples with atypical concentration patterns. Analytes with concentrations below the lower limit of detection in more than 5% of samples, or with a median absolute deviation not exceeding the detection threshold, will be excluded from further analyses. To validate the five previously identified associations, metal concentrations will be compared between patients with GBC and patients with gallstone disease using univariate and multiple robust logistic regression, adjusting for potential confounding factors and correcting probability values for multiple comparisons using the Bonferroni method.

Study Type

Observational

Enrollment (Actual)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bolivia
      • Cochabamba, Bolivia
        • 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
  • Chile
      • Arica, Chile
        • Hospital Clínico de Magallanes
      • Arica, Chile
        • Hospital Regional de Arica
      • Concepción, Chile
        • Hospital Regional de Concepción
      • Port Montt, Chile
        • Hospital De Puerto Montt
      • Rancagua, Chile
        • Hospital Regional de Rancagua
      • Santiago, Chile
        • Hospital San Juan de Dios
      • Santiago, Chile
        • Hospital Sótero del Río
      • Santiago, Chile
        • Hospital Clínico Universidad de Chile
      • Santiago, Chile
        • Clínica Alemana de Santiago
      • Santiago, Chile
        • Hospital Padre Hurtado
      • Santiago, Chile
        • Hospital Barros Luco
      • Santiago, Chile
        • Hospital del Salvador
      • Santiago, Chile
        • Fundación Arturo López Perez (FALP)
      • Santiago, Chile
        • Hospital El Pino
      • Santiago, Chile
        • Hospital San Borja
      • Talca, Chile
        • Hospital Regional de Talca
      • Temuco, Chile
        • Clínica Alemana de Temuco
      • Temuco, Chile
        • Hospital Regional de Temuco
      • Temuco, Chile
        • Complejo Asistencial Padre Las Casas
  • Germany
      • Heidelberg, Germany
        • Statistical Genetics Research Group, Institute of Medical Biometry, University of Heidelberg
  • Peru
      • Arequipa, Peru
        • Hospital Goyoneche
      • Arequipa, Peru
        • Hospital Honorio Delgado
      • Arequipa, Peru
        • Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur)
      • Juliaca, Peru
        • Clínica Monte Sinaí
      • Juliaca, Peru
        • Hospital Base III- La Capilla ESSALUD
      • Lima, Peru
        • Instituto Nacional de Enfermedades Neoplásicas (INEN)
      • Puno, Peru
        • Hospital Regional Manuel Nuñez Butrón
      • Trujillo, Peru
        • Instituto Regional de Enfermedades Neoplásicas del Norte (IREN Norte)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with gallstones and cancer-free OR - Patients with gallbladder cancer

Description

Inclusion Criteria:

  • Patients with gallstones and cancer-free OR - Patients with gallbladder cancer

Exclusion Criteria:

  • Patients younger than 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
South American patients with gallbladder cancer
Other: Research of gallbladder cancer
Pathological examination of the gallbladder after cholecystectomy
South American patients with gallstones
with no evidence of gallbladder cancer upon pathological examination of the gallbladder after cholecistectomy
Other: Research of gallbladder cancer
Pathological examination of the gallbladder after cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum concentrations of five minerals among South American gallstone patients with and without gallbladder cancer
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Paul Strauss

Collaborators

Statistical Genetics Research Group, Institute of Medical Biometry, Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

January 31, 2026

Study Completion (Actual)

January 31, 2026

Study Registration Dates

First Submitted

June 8, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Access Criteria

Upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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