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临床试验/NCT01216514
NCT01216514已完成不适用

Differential Characteristics of All Serologic Markers for Chronic Inflammatory Bowel Diseases During Clinical Forms With Weak or Strong Evolution Capacities

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
194
试验地点
1
主要终点
definition of the unstable form of Crohn disease and RCH

研究概览

简要总结

Factors forecast Chronic Inflammatory Bowel Diseases (IBD) remain at present essentially on clinical factors (extension of the disease, achievement of the perianal ring, requirement of surgery, treatment by immunomodulators...). All IBD specific immunological or serological markers showed only a diagnostic role for indefinite colitis (hemorrhagic Rectocolitis vs Crohn Disease) but were never able to be considered as predictive elements of adults IBD evolution. Among the most used, the presence of ANCA's antibody and ASCA allows to separate hemorrhagic rectocolitis (ANCA + / ASCA-) from Crohn disease (ANCA-/ASCA +) and their combination present an average sensibility about 85 % and a 85 % specificity. However, 8 other antibody types were recently isolated and estimated individually during IBD in particular during child Crohn diseases (anti-OmpC, anti-I2, anti-CBir1, anti-glycans (ALCA, AMCA and ACCA) anti-Goblet cells and albicans Candida's specific anti-mannan). These complementary assays improve significantly the reliability of the diagnosis. However, if the use of these new markers has an indisputable diagnostic role, their predictive role in the evolution of IBD was estimated at the adult's only rarely during Crohn diseases. Consequently, the investigators suggest realizing an exhaustive analysis of all these new immunological markers to define, if their association can have an interest in the differentiation of stable (or little evolutionary) and unstable (or quickly evolutionary) clinical forms.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Major Patient
  • IBD (RCH or MC) diagnosed according to the clinical, endoscopic and histological criteria
  • Accepting the sampling of blood
  • Patient member or legal successor of a national insurance scheme
  • Taken care medical in the service of gastroenterology of CHU de Saint Etienne
  • Patient having signed the form of consent

排除标准

  • Minor Patient or uncapable
  • Patient suffering from indefinite colitis
  • Refusal of the sampling of blood
  • Pregnant Woman
  • Incapacity or refusal to sign the consent writes
  • Subjects deprived of freedom by a court or administrative order
  • Use of an anti-TNF. According to the indications ensuing from the Sonic trial or from the strategy " Top Down ".

结局指标

主要结局

definition of the unstable form of Crohn disease and RCH

时间窗: day 1

Crohn disease, at least one of the following criteria: Use of anti-TNF antibody in case of immunosuppressor failure. Surgery of resection (at least two resections or more than 70 cms of intestinal resections) Anoperineal form with complex fistulas Spread intestinal affection Beginning of the disease before 16 years RCH, at least one of the following criteria: Initial pancolite affection Immunosuppresseur use in the first year of evolution Use of anti-TNF Severe Colitis

次要结局

  • Treatment effective : patient in clinical and endoscopic remission state(day 1)
  • corticodependant patient(history and day 1)
  • corticoresistant patient(history and day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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