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

8. juni 2026 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

230

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • 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)
  • Tyskland
      • Heidelberg, Tyskland
        • Statistical Genetics Research Group, Institute of Medical Biometry, University of Heidelberg

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients younger than 18 years

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
South American patients with gallbladder cancer
Andet: 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
Andet: Research of gallbladder cancer
Pathological examination of the gallbladder after cholecystectomy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Serum concentrations of five minerals among South American gallstone patients with and without gallbladder cancer
Tidsramme: Baseline
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Paul Strauss

Samarbejdspartnere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2019

Primær færdiggørelse (Faktiske)

31. januar 2026

Studieafslutning (Faktiske)

31. januar 2026

Datoer for studieregistrering

Først indsendt

8. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-011

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingsadgangskriterier

Upon request

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kliniske forsøg med Research of gallbladder cancer

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