Clinical trial · Observational
Autoimmune Pancreatitis, Pancreatic and Extrapancreatic cAnceR (AiPPEAR)
A Multicenter, Retrospective Study on Autoimmune Pancreatitis, Pancreatic and Extrapancreatic cAnceR (AiPPEAR)
NCT06328101CI-TRIAL-00075382AiPPEARunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational, retrospective study is to learn about cancer risk in autoimmune pancreatitis (AIP) patients. The main questions it aims to answer are: * Do patients with AIP have higher incidence of cancer in comparison to general population? * What is the overall prevalence of cancer in AIP patients? * What are the characteristics of AIP patients associated with the incidence of cancer?
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autoimmune Pancreatitis Type 1 | — | UNRESOLVED | — |
| Autoimmune Pancreatitis Type 2 | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- AIP_mlg
- description
- Autoimmune pancreatitis patients with cancer
- label
- AIP_nomlg
- description
- Autoimmune pancreatiits patients without cancer
- label
- general population
- description
- Cancer Incidence in Five Continents Volume XI" (CI5XI) registry patients used to determine expected cancer incidence and calculate SIR
Primary outcomes (1)
- measure
- Standardized incidence ratio (SIR) of first invasive cancer
- timeFrame
- up to 20 years
- description
- The standardized incidence ratio (SIR) of the first invasive cancer occurring after the diagnosis of AIP compared to age-grouped and gender-matched controls in the general population. We will count the incidence of invasive cancer in AIP patients (yes/no).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with AIP after 2005, including type 1, type 2, and not-otherwise-specified (NOS) AIP, regardless of the diagnostic criteria used. Exclusion Criteria: * Patients younger than 18 years at last contact * Patients with less than 12 months of follow up after diagnosis * Patients with immune checkpoint inhibitor-induced pancreatitis
References
Publications (11)
- BACKGROUNDLohr JM, Beuers U, Vujasinovic M, Alvaro D, Frokjaer JB, Buttgereit F, Capurso G, Culver EL, de-Madaria E, Della-Torre E, Detlefsen S, Dominguez-Munoz E, Czubkowski P, Ewald N, Frulloni L, Gubergrits N, Duman DG, Hackert T, Iglesias-Garcia J, Kartalis N, Laghi A, Lammert F, Lindgren F, Okhlobystin A, Oracz G, Parniczky A, Mucelli RMP, Rebours V, Rosendahl J, Schleinitz N, Schneider A, van Bommel EF, Verbeke CS, Vullierme MP, Witt H; UEG guideline working group. European Guideline on IgG4-related digestive disease - UEG and SGF evidence-based recommendations. United European Gastroenterol J. 2020 Jul;8(6):637-666. doi: 10.1177/2050640620934911. Epub 2020 Jun 18. PMID 32552502
- BACKGROUNDShimosegawa T, Chari ST, Frulloni L, Kamisawa T, Kawa S, Mino-Kenudson M, Kim MH, Kloppel G, Lerch MM, Lohr M, Notohara K, Okazaki K, Schneider A, Zhang L; International Association of Pancreatology. International consensus diagnostic criteria for autoimmune pancreatitis: guidelines of the International Association of Pancreatology. Pancreas. 2011 Apr;40(3):352-8. doi: 10.1097/MPA.0b013e3182142fd2. PMID 21412117
- BACKGROUNDNikolic S, Lanzillotta M, Panic N, Brismar TB, Moro CF, Capurso G, Della Torre E, Lohr JM, Vujasinovic M. Unraveling the relationship between autoimmune pancreatitis type 2 and inflammatory bowel disease: Results from two centers and systematic review of the literature. United European Gastroenterol J. 2022 Jun;10(5):496-506. doi: 10.1002/ueg2.12237. Epub 2022 May 8. PMID 35526270
- BACKGROUNDLee HW, Moon SH, Kim MH, Cho DH, Jun JH, Nam K, Song TJ, Park DH, Lee SS, Seo DW, Lee SK. Relapse rate and predictors of relapse in a large single center cohort of type 1 autoimmune pancreatitis: long-term follow-up results after steroid therapy with short-duration maintenance treatment. J Gastroenterol. 2018 Aug;53(8):967-977. doi: 10.1007/s00535-018-1434-6. Epub 2018 Jan 23. PMID 29362937
- BACKGROUNDLanzillotta M, Tacelli M, Falconi M, Arcidiacono PG, Capurso G, Della-Torre E. Incidence of endocrine and exocrine insufficiency in patients with autoimmune pancreatitis at diagnosis and after treatment: a systematic review and meta-analysis. Eur J Intern Med. 2022 Jun;100:83-93. doi: 10.1016/j.ejim.2022.03.014. Epub 2022 Mar 30.