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临床试验/NCT06380062
NCT06380062已完成不适用

Pre-operative Plasma Concentrations of Choline and Its Metabolites in People With Prostate Cancer Compared to Those With Benign Hyperplasia

Universität des Saarlandes1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2012年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
350
试验地点
1
主要终点
Plasma choline concentrations

研究概览

简要总结

The aim of this study was to investigate plasma concentrations of one-carbon metabolites and phospholipid classes in participants with primary prostate cancer and those with benign hyperplasia. Moreover, the metabolites were studied in relation to tumor grade and age.

详细描述

This observational study recruited participants with primary prostate cancer (cases) and those with benign hyperplasia (controls) before the surgery. Data on the outcomes of the surgery including the results of the biopsy investigation were collected. Blood samples were collected before the surgery in context of routine blood investigations. Blood plasma samples collected on ethylenediaminetetraacetic acid (EDTA) were used to measure concentrations of free choline, betaine, dimethylglycine, folate forms, S-adenosylhomocysteine, S-adenosylmethionine, homocysteine, cystathionine, and methylmalonic acid (MMA). Data on serum concentrations of prostate specific antigen (PSA) and the tumor grade and classification (Gleason Score system) were collected. The associations between the plasma concentrations of the metabolites and PSA or the Gleason score were studied. The concentrations of the metabolic markers were compared between the cases and the controls according to the age of the participants.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Men participants
  • age > 50 years
  • recently diagnosed with primary prostate cancer or benign hyperplasia

排除标准

  • vitamin B supplementation (folic acid> 400 µg / day; B12> 10 µg / day; B6> 10 mg / day)
  • renal failure
  • advanced liver disease
  • chronic alcohol consumption
  • metastases
  • methotrexate therapy.

结局指标

主要结局

Plasma choline concentrations

时间窗: through study completion, on average 1 year

Concentrations measured in plasma with liquid chromatography tandem mass spectrometry

Whole blood choline concentrations

时间窗: through study completion, on average 1 year

Concentrations measured in plasma with liquid chromatography tandem mass spectrometry

次要结局

  • Plasma homocysteine concentrations(through study completion, on average 1 year)
  • Plasma phospholipids(through study completion, on average 1 year)
  • Plasma betaine concentrations(through study completion, on average 1 year)
  • Plasma methylmalonic acid concentrations(through study completion, on average 1 year)
  • Plasma and whole blood folate forms(through study completion, on average 1 year)
  • Plasma S-adenosylmethionine concentrations(through study completion, on average 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rima Obeid

Prof. Dr.

Universität des Saarlandes

研究点 (1)

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