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临床试验/NCT01211561
NCT01211561Unknown早期 1 期

Colon Cancer Prevention Using Selenium

University of Illinois at Chicago1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
50
试验地点
1
主要终点
Reduction in ACF biomarkers

研究概览

简要总结

Selenium's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30 years, but has never been directly studied in humans. The investigators will directly assess selenium's ability to prevent CRC by measuring alterations in aberrant crypt foci (ACF), an accepted surrogate marker for CRC.

ACF's are very small (i.e., microscopic) collections of abnormally shaped cells that are a commonly used marker of CRC risk. Screening colonoscopy at UIC routinely uses methods that allow ACF counting to be done as a part of standard practice. ACF's are not fixed, like polyps or cancers, but can disappear as a person's risk for developing CRC decreases.

The investigators propose giving patient's with 6 or more ACF's 200 mcg selenized yeast or placebo, and determining if there is a drug-dependant decrease in ACF number. The primary objective is to determine whether selenized yeast supplementation, compared to placebo, causes significant reduction of ACF number from baseline levels. The primary endpoint will be change in ACF number

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • All non-pregnant patients >50 years of age

排除标准

  • The following will be specifically looked for, and result in patients not being eligible for study enrollment:
  • Use of non-steroidal anti-inflammatory drugs or glucocorticosteroids within 60 days of study entry.
  • History of chronic IBD or prior pelvic radiation (inflammation distorts crypt pattern).
  • Intake of any selenium supplements within 60 days of study entry, including vitamins.
  • Patients with increased bleeding risk from biopsy protocol (i.e. renal failure, decompensated cirrhosis, blood dyscrasia).

研究组 & 干预措施

Selenium, selenomethionine

Experimental

干预措施: Selenium, selenomethionine (Drug)

placebo

Active Comparator

干预措施: placebo (Drug)

结局指标

主要结局

Reduction in ACF biomarkers

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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