Osteopontin as a Biomarker in Pancreatitis | NCT05882500

Studies
Osteopontin as a Biomarker in Pancreatitis

NCT05882500

Sponsor

Linkoeping University

Status

Completed

Last Update Posted

May 31, 2023Actual

Enrollment

103Actual

Phase

Not provided

Conditions

Pancreatitis

Interventions

No intervention, observation

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2011Actual

Primary Completion Date

Oct 19, 2016Actual

Completion Date

Jan 31, 2023Actual

First Submitted Date

May 11, 2023

First Submission Date that Met QC Criteria

May 20, 2023

First Posted Date

May 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2023

Last Update Posted Date

May 31, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. The aim is do identifiy factors that may aid in the risk stratification for development of different severity grades of pancreatitis.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pancreatits		Patients with pancreatitis based ont the Atlanta criteria	Other: No intervention, observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention, observation	Other		Pancreatits

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Within 3 days from diagnosis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of pancreatitis

Exclusion Criteria:

Pregnancy, lactation, unable to understand the study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with diagnosis of pancreatitis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Linkoping University Hospital		Linköping		582 72	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010195	Pancreatitis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided