PancreatitisNCT00444444
Genetic Analysis for Predicting of Relapse During Steroid Treatment for Autoimmune Pancreatitis (AIP)
An observational study of Pancreatitis, run by Asan Medical Center at 1 site in South Korea.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatitis
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2002to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age below 18 years
- Pregnancy
- Active alcohol or drug abuse
- Unstable or unwilling to comply with follow up
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center
Seoul, 138-736
About this study
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
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
Read the 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).
- Conditions
- Pancreatitis
- Keywords
- Autoimmune pancreatitis, HLA, relapse, Sequence-based typing
- Medical subject headings
- Pancreatitis, Autoimmune Pancreatitis, Recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startFeb 2002
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Do Hyun Park, MD, PhD, Study director, Soon Chun Hyang UniversityMyung-Hwan Kim, MD, PhD, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444444
- Sponsor's protocol ID
- 2007-0038
- Status last verified
- Mar 2007
- First submitted
- 6 Mar 2007
- Last updated
- 26 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Park DH, Kim MH, Oh HB, Kwon OJ, Choi YJ, Lee SS, Lee TY, Seo DW, Lee SK. Substitution of aspartic acid at position 57 of the DQbeta1 affects relapse of autoimmune pancreatitis. Gastroenterology. 2008 Feb;134(2):440-6. doi: 10.1053/j.gastro.2007.11.023. Epub 2007 Nov 17.
PubMed 18155707
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00444444
- Acronym / sponsor ID
- 2007-0038
- Conditions
- Pancreatitis
- Keywords
- Autoimmune pancreatitis, HLA, relapse, Sequence-based typing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Feb 2002
- Study completion
- Jun 2007 (actual)
- First posted
- 7 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Age below 18 years
- Pregnancy
- Active alcohol or drug abuse
- Unstable or unwilling to comply with follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2007.
- Derived from this study: PubMed 18155707Park DH, Kim MH, Oh HB, Kwon OJ, Choi YJ, Lee SS, Lee TY, Seo DW, Lee SK. Substitution of aspartic acid at position 57 of the DQbeta1 affects relapse of autoimmune pancreatitis. Gastroenterology. 2008 Feb;134(2):440-6. doi: 10.1053/j.gastro.2007.11.023. Epub 2007 Nov 17.
Related trials for Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
Recruiting
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Pancreatitis, Acute
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Do Hyun Park, MD, PhD study director
Soon Chun Hyang University
Myung-Hwan Kim, MD, PhD study chair
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00444444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2007.