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临床试验/NCT01464151
NCT01464151已完成不适用

Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study

UMC Utrecht4 个研究点 分布在 1 个国家目标入组 613 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
UMC Utrecht
入组人数
613
试验地点
4
主要终点
low- or high grade dysplasia or colorectal cancer during follow-up

研究概览

简要总结

Both ulcerative colitis and Crohn's colitis are associated with an increased risk of developing colorectal cancer (CRC). Although the increased risk of CRC in colitis patients is well established, several studies show that the risk varies widely between patients, depending on the presence of risk factors. Recently, several of these risk factors were implemented in the updated British guidelines for surveillance which are now used to determine surveillance intervals in our center. The new guideline recommends stratification of patients in a high, medium or low risk group depending on the presence of clinical and endoscopic risk factors and to adjust the surveillance interval accordingly. Although these guidelines provide a first step towards an individualized surveillance regimen, current data regarding risk factors for IBD (inflammatory bowel disease) -associated CRC are solely based on retrospective studies. Prospective data on the phenotype and genotype reliably predicting the risk of CRC is needed to further optimize surveillance in the future.

Objectives:

  1. To confirm established and identify new predictive factors for colorectal cancer in a prospective cohort of IBD patients undergoing regular surveillance. Dysplasia or colorectal cancer will be the primary outcome.
  2. To provide evidence that mucosal healing results in a significant reduction of colorectal dysplasia/neoplasia in IBD patients and that this is associated with 5-ASA (5-aminosalicylic acid) or anti-TNF (tumor necrosis factor) maintenance therapy.
  3. Study the expression of several tumor markers in biopsies, blood and faeces at baseline and determine whether expression of these markers can predict dysplasia or colorectal cancer development during follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of ulcerative colitis, crohn's colitis or indeterminate colitis
  • Disease duration ≥ 8 years
  • Inflammation of at least 30% of colonic mucosa at some point between IBD diagnosis and inclusion
  • Age 18 - 70 years
  • Signed informed consent

排除标准

  • High grade dysplasia or colorectal cancer before inclusion
  • subtotal or total colectomy before inclusion
  • Clotting disorder or use of anticoagulants that can not be temporarily discontinued
  • Serious comorbidities which prevent performing a colonoscopy
  • Limited life expectancy
  • Clinical or endoscopical disease activity (at the discretion of the treating physician)

结局指标

主要结局

low- or high grade dysplasia or colorectal cancer during follow-up

时间窗: 5 years

次要结局

未报告次要终点

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

B. Oldenburg

MD, PhD

UMC Utrecht

研究点 (4)

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