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临床试验/NCT01486745
NCT01486745已完成不适用

Is There a Role for Using NMR Urine Metabolomics as a New Method of Screening for Colorectal Cancer?

University of Alberta1 个研究点 分布在 1 个国家目标入组 2,175 人开始时间: 2008年9月15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
2,175
试验地点
1

研究概览

简要总结

This is a prospective, multi-centered study to assess whether urine metabolomics can play a role in the screening of colorectal cancer (CRC). Urine samples will be collected from 1000 patients going through an established CRC screening program, and from a further 500 patients who already have a diagnosis of CRC. Using nuclear magnetic resonance (NMR) spectroscopy, the 1H NMR spectrum of urine samples will be analyzed for specific metabolites, and establish the metabolomic signature of colorectal cancer. The results from metabolomic urinalysis of this screening cohort will be compared with results from colonoscopy, histological descriptions, fecal occult blood testing (FOBT), and fecal immune testing (FIT) to assess the accuracy of urine metabolomics in identifying patients with polyps and malignancies. The urine metabolomic results from the colorectal cancer group will be correlated with operative, histological and clinical staging to define the role of urine metabolomics in assessing colorectal cancer type, location and stage. Additionally approximately 300 urine samples from breast cancer patients and 300 from prostate cancer patients will be collected to validate that the colorectal cancer signature is unique.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For Screening group (normal colonoscopy & colonic polyps):
  • asymptomatic, 50-75 year old, without personal or family history of CRC/polyps
  • asymptomatic, 40-75 year old, known personal or first-degree family history of either CRC or polyps
  • For Cancer group:
  • any patient with diagnosis of colorectal cancer
  • any patient with diagnosis of prostate cancer
  • any patient with diagnosis of breast cancer

排除标准

  • For screening group:
  • hematochezia
  • inflammatory bowel disease
  • on anticoagulation for reasons other than atrial fibrillation
  • significant co-morbidities
  • For Cancer group:
  • already had neoadjuvant treatment at time of urine collection
  • no invasive cancer at time of urine collection

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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