跳至主要内容
临床试验/NCT03096717
NCT03096717Unknown不适用

Incidence of Dysplasia and Colorectal Cancer in Patients With Chronic Idiopathic Inflammatory Colitis Treated With Biologics, Mesalamine, and Immunosuppressive Drug Combinations

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
incidence of dysplasia in relation to therapy performed

研究概览

简要总结

Chronic intestinal inflammation produce dysplasia more frequently than the normal population. The therapies protect against these changes, but do not rule out dysplasia. It is not known the effect of different therapies protection.

详细描述

The literature data show that the inflammatory bowel diseases (rectal ulcerative colitis and Crohn's disease) determine an increased risk of developing dysplasia and cancer of the colon and rectum, for the chronic inflammation that they fee, with the differences that the two diseases arise. The progression from normal mucosa to dysplasia and then to cancer is more rapid than in the adenoma-carcinoma sequence.

In patients with idiopathic chronic inflammatory colitis drug therapies in use reduce the incidence of dysplasia.

A systematic review concluded in favor of a chemo preventive effect of mesalazine. In any case, it has been reported protective association between use of mesalazine and cancer associated with colitis (colitis Associated carcinoma CAC) with an odds ratio of 0.51 per CAC / dysplasia. This data, in subsequent studies, including recent ones, have remained controversial.

The introduction of biological drugs in the treatment of patients with inflammatory bowel disease (IBD) has changed the quality of life and also the natural history of the disease. It is not known what biological drugs have improved the clinical history of these diseases by changing the incidence of dysplasia and colorectal cancer.

The treatment of idiopathic inflammatory bowel diseases (IBD), the last decade has seen profound changes and, now, the use of biological drugs is frequent in the moderate-severe forms, especially if extended. Mesalazine has in the indication of mild to moderate forms of therapy.

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
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • long standing colonic inflammatory bowel disease
  • clinical, endoscopic and histological remission
  • completeness of data

排除标准

  • important comorbidities
  • family history of colorectal cancer
  • insufficient data

结局指标

主要结局

incidence of dysplasia in relation to therapy performed

时间窗: 24 months

colonic biopsies are performed in long standing inflammatory bowel disease in relation to dysplasia detection in patients on different drugs therapy

次要结局

未报告次要终点

研究者

发起方
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
申办方类型
Other
责任方
Principal Investigator
主要研究者

alba panarese

principal investigator

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

研究点 (1)

Loading locations...

相似试验