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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Arica、チリ
- Hospital Clínico de Magallanes
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Arica、チリ
- Hospital Regional de Arica
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Concepción、チリ
- Hospital Regional de Concepcion
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Port Montt、チリ
- Hospital De Puerto Montt
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Rancagua、チリ
- Hospital Regional de Rancagua
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Santiago、チリ
- Hospital San Juan de Dios
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Santiago、チリ
- Hospital Sotero Del Rio
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Santiago、チリ
- Hospital Clinico Universidad de Chile
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Santiago、チリ
- Clinica Alemana de Santiago
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Santiago、チリ
- Hospital Padre Hurtado
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Santiago、チリ
- Hospital Barros Luco
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Santiago、チリ
- Hospital del Salvador
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Santiago、チリ
- Fundación Arturo López Pérez (FALP)
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Santiago、チリ
- Hospital El Pino
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Santiago、チリ
- Hospital San Borja
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Talca、チリ
- Hospital Regional de Talca
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Temuco、チリ
- Clínica Alemana de Temuco
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Temuco、チリ
- Hospital Regional de Temuco
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Temuco、チリ
- Complejo Asistencial Padre Las Casas
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Heidelberg、ドイツ
- Statistical Genetics Research Group, Institute of Medical Biometry, University of Heidelberg
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Arequipa、ペルー
- Hospital Goyoneche
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Arequipa、ペルー
- Hospital Honorio Delgado
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Arequipa、ペルー
- Instituto Regional de Enfermedades Neoplásicas del Sur (IREN Sur)
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Juliaca、ペルー
- Clínica Monte Sinaí
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Juliaca、ペルー
- Hospital Base III- La Capilla ESSALUD
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Lima、ペルー
- Instituto Nacional de Enfermedades Neoplásicas (INEN)
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Puno、ペルー
- Hospital Regional Manuel Nuñez Butrón
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Trujillo、ペルー
- Instituto Regional de Enfermedades Neoplásicas del Norte (IREN Norte)
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Cochabamba、ボリビア
- Complejo Hospitalario Viedma
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Cochabamba、ボリビア
- Hospital del Norte
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Cochabamba、ボリビア
- Hospital Obrero No. 2 (Caja Nacional del Seguro Social)
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Cochabamba、ボリビア
- Instituto Gastroenterológico
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Cochabamba、ボリビア
- Instituto Oncológico Nacional
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients with gallstones and cancer-free OR - Patients with gallbladder cancer
Exclusion Criteria:
- Patients younger than 18 years
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Serum concentrations of five minerals among South American gallstone patients with and without gallbladder cancer
時間枠：Baseline
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Baseline
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協力者と研究者
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有アクセス基準
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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