Acute PancreatitisDIAGNONNCT03634787
Heat Shock Proteins: a Pathogenic Driver and Potential Therapeutic Target in Acute Pancreatitis
An observational study of Acute Pancreatitis, run by Vilnius University at 1 site in Lithuania.
Trial summary
To investigate the role of Heat Shock Proteins in the mechanism of acute severe pancreatitis. In addition to test the potential treatment target of acute pancreatitis. All patients who present with clinical symptoms of acute pancreatitis are evaluated for the enrollment of the study. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- CT Scan Day 5-7
- How many people
- 280 participants
- Where
- 1 siteLithuania
- Study dates
- 20 Oct 2017to 30 Dec 2021
- 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 18 to 100 years
- All sexes
- Adult, Older adult
Study population: All patients admitted to the hospital within 48 hours since the typical symptoms of acute pancreatitis
Who may be able to join
- no prior diagnosis of acute pancreatitis
- admission to the hospital within 2 days since the clinical symptoms
- confirmed diagnosis of acute pancreatitis
Who cannot join
- chronic pancreatitis
- pancreatic cancer
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital "Santaros Klinikos
Vilnius, 08410
Kestutis Strupas, Prof.MD/PhD, +3705236500, kestutis.strupas@santa.lt
Aiste Gulla, MD, +37052365000, aiste.kielaite-gulla@santa.lt
About this study
To investigate the role of Heat Shock Proteins in the mechanism of acute severe pancreatitis. In addition to test the potential treatment target of acute pancreatitis.
All patients who present with clinical symptoms of acute pancreatitis are evaluated for the enrollment of the study.
Read the detailed description
All patients with acute pancreatitis are evaluated according to modified Atlanta classification acute pancreatitis severity scores.
Blood serum, urine and DNA samples are collected from all patients presented on admission, after 24 hours, 48 hours, 72 hours.
CT is performed in al patients to evaluate necrosis of pancreas Day 5-7 since hospital admission. If necrosis is not present follow-up is stopped.
- Conditions
- Acute Pancreatitis
- Being tested
- CT Scan Day 5-7
- Keywords
- Heat Shock Proteins, early diagnosis
- Medical subject headings
- Pancreatitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Scan Day 5-7Diagnostic test
Computed Tomography on Day 5-7 according to a clinical protocol.
| Study group | Role | What they receive |
|---|---|---|
| Acute pancreatitis | First time acute pancreatitis. No later than 2 days since the clinical symptoms started. Receives: Diagnostic Test: CT Scan Day 5-7 | |
| Healthy | No major systemic illness |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the levels of heat shock proteins in serum and plasma in acute severe pancreatitis settings
Different molecular weight Heat Shock proteins role while developing acute pancreatitis.
Measured: 2 years
Secondary outcomes (1)
To measure pancreas cells activity while applying Heat Shock Protein inhibitors
To establish a mechanism explaining the potential use of heat shock proteins inhibitors/ activators for treatment of acute pancreatitis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start20 Oct 2017
- Primary completionDec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- 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
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiste Gulla, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634787
- Sponsor's protocol ID
- 158200-17-941-455
- Acronym
- DIAGNON
- Status last verified
- Aug 2018
- First submitted
- 3 Jul 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share the data and recruitment status when the study reaches its requirement sample size
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Shock Proteins: a Pathogenic Driver and Potential Therapeutic Target in Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT03634787
- Acronym / sponsor ID
- DIAGNON / 158200-17-941-455
- Conditions
- Acute Pancreatitis
- Keywords
- Heat Shock Proteins, early diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 16 Aug 2018 (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.
To investigate the role of Heat Shock Proteins in the mechanism of acute severe pancreatitis. In addition to test the potential treatment target of acute pancreatitis.
All patients who present with clinical symptoms of acute pancreatitis are evaluated for the enrollment of the study.
Detailed description
All patients with acute pancreatitis are evaluated according to modified Atlanta classification acute pancreatitis severity scores.
Blood serum, urine and DNA samples are collected from all patients presented on admission, after 24 hours, 48 hours, 72 hours.
CT is performed in al patients to evaluate necrosis of pancreas Day 5-7 since hospital admission. If necrosis is not present follow-up is stopped.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute pancreatitis | – | Diagnostic Test: CT Scan Day 5-7First time acute pancreatitis. No later than 2 days since the clinical symptoms started. |
| Healthy | – | –No major systemic illness |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the hospital within 48 hours since the typical symptoms of acute pancreatitis
Key inclusion criteria (3 listed)
- no prior diagnosis of acute pancreatitis
- admission to the hospital within 2 days since the clinical symptoms
- confirmed diagnosis of acute pancreatitis
Key exclusion criteria (2 listed)
- chronic pancreatitis
- pancreatic cancer
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 |
|---|---|---|
| CT Scan Day 5-7Computed Tomography on Day 5-7 according to a clinical protocol. | Diagnostic test | Acute pancreatitis |
Primary outcome
To measure the levels of heat shock proteins in serum and plasma in acute severe pancreatitis settings
Time frame: 2 years
Different molecular weight Heat Shock proteins role while developing acute pancreatitis.
1 secondary outcome
To measure pancreas cells activity while applying Heat Shock Protein inhibitors
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Individual participant dataSharing planned: Undecided. We plan to share the data and recruitment status when the study reaches its requirement sample size
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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.
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 Acute Pancreatitis, run by Vilnius University at 1 site in Lithuania.
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 3 inclusion and 2 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 16 Aug 2018. 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 Lithuania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kestutis Strupas, Prof. MD/PhD (+37052365000, kestutis.strupas@santa.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the levels of heat shock proteins in serum and plasma in acute severe pancreatitis settings (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2018.