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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Heidelberg, Allemagne
- Statistical Genetics Research Group, Institute of Medical Biometry, University of Heidelberg
-
-
-
-
-
Cochabamba, Bolivie
- Complejo Hospitalario Viedma
-
Cochabamba, Bolivie
- Hospital del Norte
-
Cochabamba, Bolivie
- Hospital Obrero No. 2 (Caja Nacional del Seguro Social)
-
Cochabamba, Bolivie
- Instituto Gastroenterológico
-
Cochabamba, Bolivie
- Instituto Oncológico Nacional
-
-
-
-
-
Arica, Chili
- Hospital Clínico de Magallanes
-
Arica, Chili
- Hospital Regional de Arica
-
Concepción, Chili
- Hospital Regional de Concepcion
-
Port Montt, Chili
- Hospital De Puerto Montt
-
Rancagua, Chili
- Hospital Regional de Rancagua
-
Santiago, Chili
- Hospital San Juan de Dios
-
Santiago, Chili
- Hospital Sotero Del Rio
-
Santiago, Chili
- Hospital Clinico Universidad de Chile
-
Santiago, Chili
- Clinica Alemana de Santiago
-
Santiago, Chili
- Hospital Padre Hurtado
-
Santiago, Chili
- Hospital Barros Luco
-
Santiago, Chili
- Hospital del Salvador
-
Santiago, Chili
- Fundación Arturo López Pérez (FALP)
-
Santiago, Chili
- Hospital El Pino
-
Santiago, Chili
- Hospital San Borja
-
Talca, Chili
- Hospital Regional de Talca
-
Temuco, Chili
- Clínica Alemana de Temuco
-
Temuco, Chili
- Hospital Regional de Temuco
-
Temuco, Chili
- Complejo Asistencial Padre Las Casas
-
-
-
-
-
Arequipa, Pérou
- Hospital Goyoneche
-
Arequipa, Pérou
- Hospital Honorio Delgado
-
Arequipa, Pérou
- Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur)
-
Juliaca, Pérou
- Clínica Monte Sinaí
-
Juliaca, Pérou
- Hospital Base III- La Capilla ESSALUD
-
Lima, Pérou
- Instituto Nacional de Enfermedades Neoplásicas (INEN)
-
Puno, Pérou
- Hospital Regional Manuel Nuñez Butrón
-
Trujillo, Pérou
- Instituto Regional de Enfermedades Neoplásicas del Norte (IREN Norte)
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients with gallstones and cancer-free OR - Patients with gallbladder cancer
Exclusion Criteria:
- Patients younger than 18 years
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
South American patients with 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
|
Pathological examination of the gallbladder after cholecystectomy
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Serum concentrations of five minerals among South American gallstone patients with and without gallbladder cancer
Délai: Baseline
|
Baseline
|
Collaborateurs et enquêteurs
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-011
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Critères d'accès au partage IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .