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临床试验/NCT03482401
NCT03482401已完成不适用

Metabolic Profiling of Dietary Polyphenols and Methylxanthines in Normal and Malignant Mammary Tissues From Breast Cancer Patients

National Research Council, Spain2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Quantification of dietary polyphenols and methylxanthines in breast tissues

研究概览

简要总结

The aim is to characterise the metabolic profiling of dietary polyphenols in normal and malignant breast tissues from breast cancer patients.

详细描述

The objective of this exploratory trial is to determine the disposition and characterise the metabolic profiling of dietary polyphenols in normal and malignant glandular breast tissues from newly diagnosed breast cancer patients.

The patients consumed a polyphenol-rich dietary supplement containing 37 different phenolics and 2 methylxanthines (theobromine and caffeine) from the diagnosis to the surgery. The metabolic profiling was characterized in normal and malignant breast tissues as well as plasma and urine using UPLC-ESI-QTOF-MS/MS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible patients are those over 18 years with a newly biopsy-confirmed breast cancer, programmed surgery at least 3 days after the recruitment and no neoadjuvant treatment.

排除标准

  • Suspected intolerance to any component of fruits or vegetables.
  • Neoadjuvant chemo- or radiotherapy.
  • Urgent surgery (less than 3 days after the recruitment).
  • Patient under 18 years.
  • Patient with breast adenoma.

结局指标

主要结局

Quantification of dietary polyphenols and methylxanthines in breast tissues

时间窗: 1-24 months

Quantification of dietary polyphenols and methylxanthines in normal and malignant mammary tissues from breast cancer patients using ultra-high resolution liquid chromatography coupled to quadrupole-time-of-flight mass spectrometry (UPLC-ESI-QTOF-MS/MS). * Quantification (pmol/g) of each phenolic-derived metabolite in breast tissues. * Quantification (pmol/g) of each methylxanthine-derived metabolite in breast tissues.

次要结局

  • Quantification of dietary polyphenols and methylxanthines in plasma and urine(8-24 months)

研究者

发起方
National Research Council, Spain
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Juan Carlos Espín de Gea

Research Professor

National Research Council, Spain

研究点 (2)

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