Autoimmune Pancreatitis, Pancreatic and Extrapancreatic cAnceR (AiPPEAR)

NCT06328101 | Not Yet Recruiting

• 1 other identifier: 2023-02558
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Autoimmune Pancreatitis Type 1; Autoimmune Pancreatitis Type 2

Keywords

autoimmune pancreatitis; cancer; risk; pancreatic cancer; hepatobiliary cancer

Outcome Measures

Primary Outcomes (1)

• Standardized incidence ratio (SIR) of first invasive cancer

  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).

  up to 20 years

Secondary Outcomes (2)

• The prevalence of cancer diagnoses 12 months prior to AIP diagnosis

  12 months prior to AIP diagnosis

• Risk factor associated with cancer diagnosis.

  up to 20 years

Study Arms (3)

AIP_mlg

Autoimmune pancreatitis patients with cancer

AIP_nomlg

Autoimmune pancreatiits patients without cancer

general population

Cancer Incidence in Five Continents Volume XI" (CI5XI) registry patients used to determine expected cancer incidence and calculate SIR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tertiary centers specializing in the treatment of pancreatitis worldwide will be invited to participate in the study. Patients with AIP will be identified locally, and information for characterization of risk factors, AIP, and cancer will be retrospectively extracted from the medical files. The core group comprises six centers from Denmark, Germany, Slovenia, and Estonia.

You may qualify if:

• Patients diagnosed with AIP after 2005, including type 1, type 2, and not-otherwise-specified (NOS) AIP, regardless of the diagnostic criteria used.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Goettingen: lead
• University Medical Centre Maribor: collaborator
• Aalborg University Hospital: collaborator
• University Hospital Munich: collaborator
• Tartu University Hospital: collaborator
• University Hospital in Halle: collaborator

Related Publications (11)

• Lohr 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 BACKGROUND

• Shimosegawa 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 BACKGROUND

• Nikolic 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 BACKGROUND

• Lee 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 BACKGROUND

• Lanzillotta 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.

  PMID: 35367110 BACKGROUND

• Nikolic S, Maisonneuve P, Dahlman I, Lohr JM, Vujasinovic M. Exocrine and Endocrine Insufficiency in Autoimmune Pancreatitis: A Matter of Treatment or Time? J Clin Med. 2022 Jun 28;11(13):3724. doi: 10.3390/jcm11133724.

  PMID: 35807009 BACKGROUND

• Lowenfels AB, Maisonneuve P, Cavallini G, Ammann RW, Lankisch PG, Andersen JR, Dimagno EP, Andren-Sandberg A, Domellof L. Pancreatitis and the risk of pancreatic cancer. International Pancreatitis Study Group. N Engl J Med. 1993 May 20;328(20):1433-7. doi: 10.1056/NEJM199305203282001.

  PMID: 8479461 BACKGROUND

• Kurita Y, Kubota K, Fujita Y, Tsujino S, Sekino Y, Kasuga N, Iwasaki A, Iwase M, Izuka T, Kagawa K, Tanida E, Yagi S, Hasegawa S, Sato T, Hosono K, Kobayashi N, Ichikawa Y, Nakajima A, Endo I. IgG4-related pancreatobiliary diseases could be associated with onset of pancreatobiliary cancer: A multicenter cohort study. J Hepatobiliary Pancreat Sci. 2024 Mar;31(3):173-182. doi: 10.1002/jhbp.1404. Epub 2023 Dec 20.

  PMID: 38124014 BACKGROUND

• Shiokawa M, Kodama Y, Yoshimura K, Kawanami C, Mimura J, Yamashita Y, Asada M, Kikuyama M, Okabe Y, Inokuma T, Ohana M, Kokuryu H, Takeda K, Tsuji Y, Minami R, Sakuma Y, Kuriyama K, Ota Y, Tanabe W, Maruno T, Kurita A, Sawai Y, Uza N, Watanabe T, Haga H, Chiba T. Risk of cancer in patients with autoimmune pancreatitis. Am J Gastroenterol. 2013 Apr;108(4):610-7. doi: 10.1038/ajg.2012.465. Epub 2013 Jan 15.

  PMID: 23318486 BACKGROUND

• Schneider A, Hirth M, Munch M, Weiss C, Lohr JM, Ebert MP, Pfutzer RH. Risk of Cancer in Patients with Autoimmune Pancreatitis: A Single-Center Experience from Germany. Digestion. 2017;95(2):172-180. doi: 10.1159/000455963. Epub 2017 Feb 23.

  PMID: 28226313 BACKGROUND

• Cardinal von Widdern J, Knoph CS, Kase K, Regel I, Rosendahl J, Ammer-Hermenau C, Nikolic S. Autoimmune pancreatitis, pancreatic and extrapancreatic cancer (AIPPEAR): a multicentre, retrospective study protocol. BMJ Open. 2025 Feb 16;15(2):e086824. doi: 10.1136/bmjopen-2024-086824.

  PMID: 39956600 DERIVED

MeSH Terms

Conditions

Autoimmune Pancreatitis; Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Pancreatitis, Chronic; Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Endocrine System Diseases

Study Officials

• Cecilie Siggaard Knoph, MD

  Univesity Hospital Alborg

  PRINCIPAL INVESTIGATOR

• Julian Cardinal von Widdern, MD

  University Hospital Halle (Saale)

  PRINCIPAL INVESTIGATOR

• Karri Kasse, MD

  Tartu University Hospital

  PRINCIPAL INVESTIGATOR

• Ivonne Regel, PhD

  University Hospital of Munich (LMU)

  STUDY CHAIR

• Jonas Rosendahl, MD, PhD

  University Hospital Halle (Saale)

  STUDY CHAIR

Central Study Contacts

Sara Nikolić, MD

CONTACT

+38651261676; s.nikolic91@gmail.com

Christoph Ammer Herrmenau, MD

CONTACT

+491704075339; christoph.herrmenau@med.uni-goettingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 25, 2024
• Study Start: May 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: April 1, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share