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
  Purpose

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


Condition
Pancreatitis

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Enrollment: 40
Study Start Date: February 2002
Study Completion Date: June 2007
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00444444

Locations
Korea, Republic of
Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Study Director: Do Hyun Park, MD, PhD Soon Chun Hyang University
Study Chair: Myung-Hwan Kim, MD, PhD Asan Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00444444     History of Changes
Other Study ID Numbers: 2007-0038
Study First Received: March 6, 2007
Last Updated: June 25, 2007
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Autoimmune pancreatitis, HLA, relapse, Sequence-based typing

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014