Genetic Analysis for Predicting of Relapse During Steroid Treatment for Autoimmune Pancreatitis (AIP)

This study has been completed.
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00444444
First received: March 6, 2007
Last updated: June 25, 2007
Last verified: March 2007

March 6, 2007
June 25, 2007
February 2002
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Complete list of historical versions of study NCT00444444 on ClinicalTrials.gov Archive Site
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Genetic Analysis for Predicting of Relapse During Steroid Treatment for Autoimmune Pancreatitis (AIP)
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

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

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).

Observational
Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
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Pancreatitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2007
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Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age below 18 years
  • Pregnancy
  • Active alcohol or drug abuse
  • Unstable or unwilling to comply with follow up
Both
19 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00444444
2007-0038
No
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Asan Medical Center
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Study Director: Do Hyun Park, MD, PhD Soon Chun Hyang University
Study Chair: Myung-Hwan Kim, MD, PhD Asan Medical Center
Asan Medical Center
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP