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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Heidelberg, Alemania
- Statistical Genetics Research Group, Institute of Medical Biometry, University of Heidelberg
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Cochabamba, Bolivia
- Complejo Hospitalario Viedma
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Cochabamba, Bolivia
- Hospital del Norte
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Cochabamba, Bolivia
- Hospital Obrero No. 2 (Caja Nacional del Seguro Social)
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Cochabamba, Bolivia
- Instituto Gastroenterológico
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Cochabamba, Bolivia
- Instituto Oncológico Nacional
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Arica, Chile
- Hospital Clínico de Magallanes
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Arica, Chile
- Hospital Regional de Arica
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Concepción, Chile
- Hospital Regional de Concepcion
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Port Montt, Chile
- Hospital De Puerto Montt
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Rancagua, Chile
- Hospital Regional de Rancagua
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Santiago, Chile
- Hospital San Juan de Dios
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Santiago, Chile
- Hospital Sotero Del Rio
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Santiago, Chile
- Hospital Clinico Universidad de Chile
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Santiago, Chile
- Clinica Alemana de Santiago
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Santiago, Chile
- Hospital Padre Hurtado
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Santiago, Chile
- Hospital Barros Luco
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Santiago, Chile
- Hospital del Salvador
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Santiago, Chile
- Fundacion Arturo Lopez Perez (FALP)
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Santiago, Chile
- Hospital El Pino
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Santiago, Chile
- Hospital San Borja
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Talca, Chile
- Hospital Regional de Talca
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Temuco, Chile
- Clínica Alemana de Temuco
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Temuco, Chile
- Hospital Regional de Temuco
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Temuco, Chile
- Complejo Asistencial Padre Las Casas
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Arequipa, Perú
- Hospital Goyoneche
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Arequipa, Perú
- Hospital Honorio Delgado
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Arequipa, Perú
- Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur)
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Juliaca, Perú
- Clínica Monte Sinaí
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Juliaca, Perú
- Hospital Base III- La Capilla ESSALUD
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Lima, Perú
- Instituto Nacional de Enfermedades Neoplásicas (INEN)
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Puno, Perú
- Hospital Regional Manuel Nuñez Butrón
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Trujillo, Perú
- Instituto Regional de Enfermedades Neoplásicas del Norte (IREN Norte)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients with gallstones and cancer-free OR - Patients with gallbladder cancer
Exclusion Criteria:
- Patients younger than 18 years
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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South American patients with gallbladder cancer
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Pathological examination of the gallbladder after cholecystectomy
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South American patients with gallstones
with no evidence of gallbladder cancer upon pathological examination of the gallbladder after cholecistectomy
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Pathological examination of the gallbladder after cholecystectomy
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Serum concentrations of five minerals among South American gallstone patients with and without gallbladder cancer
Periodo de tiempo: Baseline
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Baseline
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-011
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Criterios de acceso compartido de IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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