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临床试验/NCT00444444
NCT00444444已完成不适用

Clinical Analysis for Predicting of Relapse During Steroid Treatment for Autoimmune Pancreatitis (AIP) in Korean Population Based on the HLA Analysis by Using a High Resolution (Sequence Based) Techniques

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2002年2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
40
试验地点
1

研究概览

简要总结

To determine whether certain alleles or haplotypes of major histocompatibility complex gene are associated with AIP in Korean population, we undertook this study with high-resolution typing for HLA (sequence-based typing).

Primary outcomes: detection of novel allele associated with AIP in Korean population Secondary outcomes: detection of genetic factor for relapse of AIP during steroid treatment

详细描述

Autoimmune chronic pancreatitis (AIP) can be defined as a chronic inflammation of the pancreas due to an autoimmune mechanism; autoimmunity is responsible for producing the pancreatic lesion. AIP is a distinctive type of chronic pancreatitis that shows reversible improvement of pancreatic morphology and function with oral steroid therapy, in comparison to other types of chronic pancreatitis which hardly respond to various treatments. AIP is increasingly being recognized to be a worldwide entity. The sudden increment in cases reported probably reflects the growing awareness of the entity, rather than a rise in the true incidence. In previous Japanese report, HLA DRB1*0405-DQB*0401 haplotype may be associated with autoimmune pancreatitis in the Japanese population. However, to date there was no subsequent data for supporting these results. In addition, this Japanese study had a limitation in methodology by using a low-resolution typing for HLA. Although this entity is well responsive to steroid therapy, relapse of AIP during steroid treatment is not uncommon. Unfortunately, there has been no laboratory or genetic predictor for responsiveness to steroid therapy in patients with AIP. To further clarify and confirm high-risk and protective genotypes for autoimmune diseases, therefore, high-resolution typing for HLA should be needed. Thus, to determine whether certain alleles or haplotypes of major histocompatibility complex gene are associated with AIP in Korean population, we undertook this study with high-resolution typing for HLA (sequence-based typing).

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

入选标准

  • Patient with autoimmune pancreatitis
  • The diagnosis is mainly based on the following three characteristic findings proposed by Japan Pancreas Society in 2002: (1)Imaging studies: irregular narrowing of the main pancreatic duct and diffuse enlargement of the pancreas, (2) Laboratory data: elevated serum IgG or the presence of autoantibodies, (3) Histological examinations: fibrotic changes with lymphoplasmacytic infiltration in the pancreatic tissue.
  • Age 18 years and above
  • No serious medical or psychological condition that would preclude study treatment
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

排除标准

  • Age below 18 years
  • Pregnancy
  • Active alcohol or drug abuse
  • Unstable or unwilling to comply with follow up

研究者

申办方类型
Other

研究点 (1)

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