PancreatitisPtitStudienNCT05882500
Osteopontin as a Biomarker in Pancreatitis
An observational study of Pancreatitis, run by Linkoeping University at 1 site in Sweden.
Trial summary
In the early phase of pancreatits, factors that can give information about the development of severety are still lacking. In this study patients will be included prospectively upon the diagnosis of pancreatits and clinical as well as labarotory and radiological factors will be sampled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- How many people
- 103 participants
- Where
- 1 siteSweden
- Study dates
- 3 Mar 2011to 31 Jan 2023
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with diagnosis of pancreatitis
Who may be able to join
- Diagnosis of pancreatitis
Who cannot join
- Pregnancy, lactation, unable to understand the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteopontin and Other Potential Biomarkers and Factors Important for Prognosis in Pancreatitis
In the early phase of pancreatits, factors that can give information about the development of severety are still lacking. In this study patients will be included prospectively upon the diagnosis of pancreatits and clinical as well as labarotory and radiological factors will be sampled. The aim is do identifiy factors that may aid in the risk stratification for development of different severity grades of pancreatitis.
Read the detailed description
In the early phase of pancreatits, factors that can give information about the development of severety are still lacking. In this study patients will be included prospectively upon the diagnosis of pancreatits and clinical as well as labarotory and radiological factors will be sampled. The aim is do identifiy factors that may aid in the risk stratification for development of different severity grades of pancreatitis.
Patients admitted and diagnosed with pancreatitis (according to the Atlanta criteria) will have serial testing of se-osteopontin in addiation to rutine blood work. Computet tomograpy and chest x-ray are mandatory as is blood culture.
- Conditions
- Pancreatitis
- Being tested
- No intervention, observation
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observationOther
| Study group | Role | What they receive |
|---|---|---|
| Pancreatits | Patients with pancreatitis based ont the Atlanta criteria Receives: Other: No intervention, observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Se-osteopontin
Se-osteopontin will be measured at admission and on day 2 and 3 of hospital stay. The change over time will be correlated to severety of pancreatitis as classified in the current Atlanta classification.
Measured: Within 3 days from diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start3 Mar 2011
- Primary completion19 Oct 2016
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by Linkoeping 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bergthor Björnsson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882500
- Sponsor's protocol ID
- PtitStudien
- Acronym
- PtitStudien
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopontin and Other Potential Biomarkers and Factors Important for Prognosis in Pancreatitis
- ClinicalTrials.gov ID
- NCT05882500
- Acronym / sponsor ID
- PtitStudien / PtitStudien
- Conditions
- Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 3 Mar 2011 (actual)
- Primary completion
- 19 Oct 2016 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 31 May 2023 (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.
In the early phase of pancreatits, factors that can give information about the development of severety are still lacking. In this study patients will be included prospectively upon the diagnosis of pancreatits and clinical as well as labarotory and radiological factors will be sampled. The aim is do identifiy factors that may aid in the risk stratification for development of different severity grades of pancreatitis.
Detailed description
In the early phase of pancreatits, factors that can give information about the development of severety are still lacking. In this study patients will be included prospectively upon the diagnosis of pancreatits and clinical as well as labarotory and radiological factors will be sampled. The aim is do identifiy factors that may aid in the risk stratification for development of different severity grades of pancreatitis.
Patients admitted and diagnosed with pancreatitis (according to the Atlanta criteria) will have serial testing of se-osteopontin in addiation to rutine blood work. Computet tomograpy and chest x-ray are mandatory as is blood culture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatits | – | Other: No intervention, observationPatients with pancreatitis based ont the Atlanta criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of pancreatitis
Key inclusion criteria (1 listed)
- Diagnosis of pancreatitis
Key exclusion criteria (1 listed)
- Pregnancy, lactation, unable to understand the study
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 |
|---|---|---|
| No intervention, observation | Other | Pancreatits |
Primary outcome
Se-osteopontin
Time frame: Within 3 days from diagnosis
Se-osteopontin will be measured at admission and on day 2 and 3 of hospital stay. The change over time will be correlated to severety of pancreatitis as classified in the current Atlanta classification.
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 31 May 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Linkoeping University at 1 site in Sweden.
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 1 inclusion and 1 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 31 May 2023. 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 Sweden. 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.
What does the primary outcome measure?
Se-osteopontin (time frame: Within 3 days from diagnosis). 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 31 May 2023.