Acute PancreatitisNCT03830073
Assessment of the Different Etiological and Susceptibility Markers in Patients With Pancreatitis: Investigating IG4, Cytomegalovirus, Coxsackie- Virus, Genetic Polymorphism of Vitamin D Receptor Gene
An observational study of Acute Pancreatitis, run by Assiut University.
Trial summary
Acute pancreatitis (AP) is a multifactorial disease. AP represents a significant number of hospital admissions. Most of the patients are admitted in an acute setting. Early identification of its etiology is an essential step toward the rational approach, both for its implications in the immediate therapy and the… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Measurement of VDR genetic polymorphism
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 20 Jun 2019
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Acute pancreatitis
Who may be able to join
- Patients with a confirmed diagnosis of acute pancreatitis.
- Patients of age 20 years or more who are willing to participate in the study and give their consent for same.
Who cannot join
- with a history of severe liver disease,
- sepsis
- Chest disease.
Trial locations and contacts
No sites are listed yet.
About this study
Acute pancreatitis (AP) is a multifactorial disease. AP represents a significant number of hospital admissions. Most of the patients are admitted in an acute setting. Early identification of its etiology is an essential step toward the rational approach, both for its implications in the immediate therapy and the prevention of recurrence. Although often obvious, the etiological workup of acute pancreatitis can be challenging.
Read the detailed description
Acute pancreatitis is the most common pancreatic disorder. Although acute pancreatitis is a benign disease, it often progresses to a serious state, and mortality is still high. Autoimmune pancreatitis (AIP) was first used to describe cases of pancreatitis with narrowing of the pancreatic duct, enlargement of the pancreas, hyper-γ-globulinaemia, and antinuclear antibody (ANA) positivity serologically by indirect immunofluorescence (IIF). The main differential diagnosis is pancreatic cancer, which can be ruled out through radiological, serological, and histological investigations.
Cytomegalovirus (CMV) is a common viral pathogen in humans. It is a lytic virus that causes a cytopathic effect in vitro and in vivo. Seroprevalence for CMV worldwide ranges from 60%-100% but the severity of illness varies. Primary CMV may be asymptomatic or may cause a mild and self-limiting mononucleosis-like syndrome. The self-limiting course of CMV infection typically includes fever, malaise, splenomegaly, mild hepatomegaly, small increases in serum transaminase activity, and variable elevation of serum alkaline phosphatase. CMV infection can cause severe hepatitis, meningitis, encephalitis, myelitis, colitis, pancreatitis and pneumonitis. Coxsackie-B virus can also cause acute pancreatitis.
VDR are also expressed on pancreatic Ɓ cells, and may play an essential role in maintaining normal insulin levels in accordance to glucose concentrations and to maintain glucose tolerance. Because vitamin D acts through VDR, their impairment or reduced functionality, e.g., as a result of polymorphisms occurring in the VDR gene, may have a crucial impact on the balance in the vitamin D concentration in the circulation, and the final metabolite activity throughout the body.
- Conditions
- Acute Pancreatitis
- Being tested
- Measurement of VDR genetic polymorphism
- Keywords
- Cytomegalovirus, Coxsackie- virus, Vitamin D receptor gene, IG4, Autoimmune pancreatitis
- Medical subject headings
- Pancreatitis, Coxsackievirus Infections, Autoimmune Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of VDR genetic polymorphismGenetic
VDR genetic polymorphism will be measured by RFLP and correlated with viral, autoimmune markers.
| Study group | Role | What they receive |
|---|---|---|
| Group I: | Seventy patients with pancreatitis Receives: Genetic: Measurement of VDR genetic polymorphism | |
| Group II: | Thirty healthy controls Receives: Genetic: Measurement of VDR genetic polymorphism |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean difference of single nucleotide polymorphism of VDR between pancreatitis patients and healthy controls
Single nucleotide polymorphism of VDR mean difference will be measured by restriction fragment length polymorphism.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion20 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham I El-mahdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830073
- Sponsor's protocol ID
- Autoimmune pancreatitis
- Status last verified
- Feb 2019
- First submitted
- 2 Feb 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cieslinska A, Kostyra E, Fiedorowicz E, Snarska J, Kordulewska N, Kiper K, Savelkoul HFJ. Single Nucleotide Polymorphisms in the Vitamin D Receptor Gene (VDR) May Have an Impact on Acute Pancreatitis (AP) Development: A Prospective Study in Populations of AP Patients and Alcohol-Abuse Controls. Int J Mol Sci. 2018 Jun 29;19(7):1919. doi: 10.3390/ijms19071919.
PubMed 29966312Chan A, Bazerbachi F, Hanson B, Alraies MC, Duran-Nelson A. Cytomegalovirus hepatitis and pancreatitis in the immunocompetent. Ochsner J. 2014 Summer;14(2):295-9.
PubMed 24940147Shimizu K, Tahara J, Takayama Y, Akao J, Ajihara T, Nagao K, Shiratori K, Tokushige K. Assessment of the Rate of Decrease in Serum IgG4 Level of Autoimmune Pancreatitis Patients in Response to Initial Steroid Therapy as a Predictor of Subsequent Relapse. Pancreas. 2016 Oct;45(9):1341-6. doi: 10.1097/MPA.0000000000000633.
PubMed 27171510Ozsvar Z, Deak J, Pap A. Possible role of Coxsackie-B virus infection in pancreatitis. Int J Pancreatol. 1992 Apr;11(2):105-8. doi: 10.1007/BF02925981.
PubMed 1318913
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Different Etiological and Susceptibility Markers in Patients With Pancreatitis: Investigating IG4, Cytomegalovirus, Coxsackie- Virus, Genetic Polymorphism of Vitamin D Receptor Gene
- ClinicalTrials.gov ID
- NCT03830073
- Acronym / sponsor ID
- Autoimmune pancreatitis
- Conditions
- Acute Pancreatitis
- Keywords
- Cytomegalovirus, Coxsackie- virus, Vitamin D receptor gene, IG4, Autoimmune pancreatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 20 Jun 2019 (estimated)
- First posted
- 5 Feb 2019 (actual)
- 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.
Acute pancreatitis (AP) is a multifactorial disease. AP represents a significant number of hospital admissions. Most of the patients are admitted in an acute setting. Early identification of its etiology is an essential step toward the rational approach, both for its implications in the immediate therapy and the prevention of recurrence. Although often obvious, the etiological workup of acute pancreatitis can be challenging.
Detailed description
Acute pancreatitis is the most common pancreatic disorder. Although acute pancreatitis is a benign disease, it often progresses to a serious state, and mortality is still high. Autoimmune pancreatitis (AIP) was first used to describe cases of pancreatitis with narrowing of the pancreatic duct, enlargement of the pancreas, hyper-γ-globulinaemia, and antinuclear antibody (ANA) positivity serologically by indirect immunofluorescence (IIF). The main differential diagnosis is pancreatic cancer, which can be ruled out through radiological, serological, and histological investigations.
Cytomegalovirus (CMV) is a common viral pathogen in humans. It is a lytic virus that causes a cytopathic effect in vitro and in vivo. Seroprevalence for CMV worldwide ranges from 60%-100% but the severity of illness varies. Primary CMV may be asymptomatic or may cause a mild and self-limiting mononucleosis-like syndrome. The self-limiting course of CMV infection typically includes fever, malaise, splenomegaly, mild hepatomegaly, small increases in serum transaminase activity, and variable elevation of serum alkaline phosphatase. CMV infection can cause severe hepatitis, meningitis, encephalitis, myelitis, colitis, pancreatitis and pneumonitis. Coxsackie-B virus can also cause acute pancreatitis.
VDR are also expressed on pancreatic Ɓ cells, and may play an essential role in maintaining normal insulin levels in accordance to glucose concentrations and to maintain glucose tolerance. Because vitamin D acts through VDR, their impairment or reduced functionality, e.g., as a result of polymorphisms occurring in the VDR gene, may have a crucial impact on the balance in the vitamin D concentration in the circulation, and the final metabolite activity throughout the body.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: | – | Genetic: Measurement of VDR genetic polymorphismSeventy patients with pancreatitis |
| Group II: | – | Genetic: Measurement of VDR genetic polymorphismThirty healthy controls |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Acute pancreatitis
Key inclusion criteria (2 listed)
- Patients with a confirmed diagnosis of acute pancreatitis.
- Patients of age 20 years or more who are willing to participate in the study and give their consent for same.
Key exclusion criteria (3 listed)
- with a history of severe liver disease,
- sepsis
- Chest disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of VDR genetic polymorphismVDR genetic polymorphism will be measured by RFLP and correlated with viral, autoimmune markers. | Genetic | Group I:, Group II: |
Primary outcome
The mean difference of single nucleotide polymorphism of VDR between pancreatitis patients and healthy controls
Time frame: Baseline
Single nucleotide polymorphism of VDR mean difference will be measured by restriction fragment length polymorphism.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Background: PubMed 29966312Cieslinska A, Kostyra E, Fiedorowicz E, Snarska J, Kordulewska N, Kiper K, Savelkoul HFJ. Single Nucleotide Polymorphisms in the Vitamin D Receptor Gene (VDR) May Have an Impact on Acute Pancreatitis (AP) Development: A Prospective Study in Populations of AP Patients and Alcohol-Abuse Controls. Int J Mol Sci. 2018 Jun 29;19(7):1919. doi: 10.3390/ijms19071919.
- Background: PubMed 24940147Chan A, Bazerbachi F, Hanson B, Alraies MC, Duran-Nelson A. Cytomegalovirus hepatitis and pancreatitis in the immunocompetent. Ochsner J. 2014 Summer;14(2):295-9.
- Background: PubMed 27171510Shimizu K, Tahara J, Takayama Y, Akao J, Ajihara T, Nagao K, Shiratori K, Tokushige K. Assessment of the Rate of Decrease in Serum IgG4 Level of Autoimmune Pancreatitis Patients in Response to Initial Steroid Therapy as a Predictor of Subsequent Relapse. Pancreas. 2016 Oct;45(9):1341-6. doi: 10.1097/MPA.0000000000000633.
- Background: PubMed 1318913Ozsvar Z, Deak J, Pap A. Possible role of Coxsackie-B virus infection in pancreatitis. Int J Pancreatol. 1992 Apr;11(2):105-8. doi: 10.1007/BF02925981.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Assiut University.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact reham elmahdy (+201002714637, reham.elmahdy@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean difference of single nucleotide polymorphism of VDR between pancreatitis patients and healthy controls (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03830073, which also lists 4 linked publications.
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 5 Feb 2019.