此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年6月8日 更新者：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

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (实际的)

230

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 德国
      • Heidelberg、德国
        • Statistical Genetics Research Group, Institute of Medical Biometry, University of Heidelberg
  • 智利
      • Arica、智利
        • Hospital Clínico de Magallanes
      • Arica、智利
        • Hospital Regional de Arica
      • Concepción、智利
        • Hospital Regional de Concepcion
      • Port Montt、智利
        • Hospital De Puerto Montt
      • Rancagua、智利
        • Hospital Regional de Rancagua
      • Santiago、智利
        • Hospital San Juan de Dios
      • Santiago、智利
        • Hospital Sotero Del Rio
      • Santiago、智利
        • Hospital Clinico Universidad de Chile
      • Santiago、智利
        • Clinica Alemana de Santiago
      • Santiago、智利
        • Hospital Padre Hurtado
      • Santiago、智利
        • Hospital Barros Luco
      • Santiago、智利
        • Hospital del Salvador
      • Santiago、智利
        • Fundación Arturo López Pérez (FALP)
      • Santiago、智利
        • Hospital El Pino
      • Santiago、智利
        • Hospital San Borja
      • Talca、智利
        • Hospital Regional de Talca
      • Temuco、智利
        • Clínica Alemana de Temuco
      • Temuco、智利
        • Hospital Regional de Temuco
      • Temuco、智利
        • Complejo Asistencial Padre Las Casas
  • 玻利维亚
      • Cochabamba、玻利维亚
        • Complejo Hospitalario Viedma
      • Cochabamba、玻利维亚
        • Hospital del Norte
      • Cochabamba、玻利维亚
        • Hospital Obrero No. 2 (Caja Nacional del Seguro Social)
      • Cochabamba、玻利维亚
        • Instituto Gastroenterológico
      • Cochabamba、玻利维亚
        • Instituto Oncológico Nacional
  • 秘鲁
      • Arequipa、秘鲁
        • Hospital Goyoneche
      • Arequipa、秘鲁
        • Hospital Honorio Delgado
      • Arequipa、秘鲁
        • Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur)
      • Juliaca、秘鲁
        • Clínica Monte Sinaí
      • Juliaca、秘鲁
        • Hospital Base III- La Capilla ESSALUD
      • Lima、秘鲁
        • Instituto Nacional de Enfermedades Neoplásicas (INEN)
      • Puno、秘鲁
        • Hospital Regional Manuel Nuñez Butrón
      • Trujillo、秘鲁
        • Instituto Regional de Enfermedades Neoplásicas del Norte (IREN Norte)

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

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

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients younger than 18 years

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
South American patients with gallbladder cancer
其他：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
其他：Research of gallbladder cancer
Pathological examination of the gallbladder after cholecystectomy

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Serum concentrations of five minerals among South American gallstone patients with and without gallbladder cancer
大体时间：Baseline
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Centre Paul Strauss

合作者

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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年12月1日

初级完成 (实际的)

2026年1月31日

研究完成 (实际的)

2026年1月31日

研究注册日期

首次提交

2026年6月8日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月11日

上次提交的符合 QC 标准的更新

2026年6月8日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2026-011

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享访问标准

Upon request

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅