AiPPEAR: a multicentric study on Autoimmune Pancreatitis, Pancreatic and Extrapancreatic cAnceR

Overview
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Autoimmune pancreatitis (AIP) occurs in two distinct forms with differing clinical and prognostic features, and prior studies suggest patients with AIP may face a higher cancer risk. This international, multicentre retrospective study will analyze data from individuals diagnosed with AIP since 2005. Its primary goal is to compare cancer incidence in AIP patients with that of the general population using standardized methods. Secondary objectives include examining cancer diagnoses shortly before AIP onset and identifying AIP characteristics linked to malignancy.

Programme: This Project is not associated with a Programme

SEEK ID: https://ldh.diz-umg.imise.uni-leipzig.de/projects/3

Public web page: https://bmjopen.bmj.com/content/15/2/e086824

NFDI4Health PALs: No PALs for this Project

Project start date: 1st Sep 2023

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : nfdi4health-29993

Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : AiPPEAR: a multicentric study on Autoimmune Pancreatitis, Pancreatic and Extrapancreatic cAnceR
Language of the title/name : English

Acronym(s) of the Project

Acronym : AiPPEAR
Language of the acronym : English

Description(s) of the Project

Description : Autoimmune pancreatitis (AIP) occurs in two distinct forms with differing clinical and prognostic features, and prior studies suggest patients with AIP may face a higher cancer risk. This international, multicentre retrospective study will analyze data from individuals diagnosed with AIP since 2005. Its primary goal is to compare cancer incidence in AIP patients with that of the general population using standardized methods. Secondary objectives include examining cancer diagnoses shortly before AIP onset and identifying AIP characteristics linked to malignancy.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Autoimmune pancreatitis, AIP, cancer

Language(s) of the project : English

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Project member
Given name(*) : Ali Alexander
Family name(s)(*) : Aghdassi
Digital identifier(s)
Identifier(*) : 0000-0002-0569-7316
Scheme(*) : ORCID
Email address : Ali.Aghdassi@med.uni-greifswald.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin A
Address : Ferdinand-Sauerbruch-Straße, 17475, Greifswald, Deutschland
Web page : https://www.medizin.uni-greifswald.de/inn_a/index.php?id=557
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : NCT (ClinicalTrials.gov)
Identifier(*) : NCT06328101

Characteristics of the Project

Is it an interventional or non-interventional Project? : Non-interventional
Specification of the type of the Project
Interventional Project type : []
Non-interventional Project type : Cohort
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Autoimmune pancreatitis (AIP)
Terminology/classification(*) : Free text
Code of the health condition or disease : Not specified
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Other
On which diseases or conditions were the data collected? : []
Collects mortality data? : Yes, with cause of death
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Ongoing (II): Recruitment and data collection ongoing
Participants enrolled by invitation? : Not specified
Start date : 1 September 2023
End date : Not specified
Mono- or multicentric? : Multicentric
Number of centers : 5
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : Male, Female, Diverse
Inclusion criteria : Patients with a diagnosis of AIP after 2005. This concerns type 1, type 2 and not-otherwise-specified (NOS) AIP regardless which diagnostic criteria were used.
Exclusion criteria : Younger than 18 years at last contact; Less than 12 months of follow up; Immune checkpoint inhibitor-induced pancreatitis
Population of the Project(*)
Coverage : International
Country(ies) : Germany, Denmark, Slovenia, Estonia
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : Not specified
Type of the intervention : Not specified
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Autoimmune pancreatitis (AIP)
Type of the exposure : Other
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : The primary aim of this study is to determine the incidence of any first invasive cancer in all patients diagnosed with AIP.
Description of the outcome measure : Not specified
Type of the outcome measure : Primary
Time point(s) of assessment : Not specified
Name of the outcome measure(*) : The secondary aims are to determine characteristics of AIP patients associated with the incidence of cancer and the overall prevalence of cancer in AIP patients.
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Not specified
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Undecided, it is not yet known if data will be made available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : Retrospective
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not specified
Masking of intervention(s) assignment
Masking implemented? : Not specified
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

AiPPEAR: a multicentric study on Autoimmune Pancreatitis, Pancreatic and Extrapancreatic cAnceR

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