Autoimmune Pancreatitis, Pancreatic and Extrapancreatic cAnceR (AiPPEAR) (AiPPEAR)

March 20, 2024 updated by: Christoph Ammer-Herrmenau, University Medical Center Goettingen

A Multicenter, Retrospective Study on Autoimmune Pancreatitis, Pancreatic and Extrapancreatic cAnceR (AiPPEAR)

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?

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Autoimmune pancreatitis (AIP) is a relapsing form of pancreatitis, comprising two histological entities with differing clinical, serological, and prognostic characteristics. Type 1 AIP is a pancreatic manifestation of IgG4-related disease, while type 2 AIP is an isolated pancreatic disorder strongly associated with the simultaneous occurrence of inflammatory bowel disease (IBD). AIP patients, particularly type 1, face a risk of relapse and may develop exocrine and endocrine pancreatic insufficiency. While it's widely acknowledged that chronic pancreatitis increases the risk of pancreatic cancer, the association between AIP and pancreatic cancer remains more controversial. AIP can imitate pancreatic cancer, and coincidence has been reported. Retrospective data from Japan suggested a high risk of pancreatic cancer and bile duct cancer in patients with AIP. However, there is a paucity of specific data on the relationship between AIP and pancreatic cancer. Japanese studies have suggested a higher incidence of extrapancreatic cancer in AIP patients compared to the general population. German single-center data support this claim. The most frequently reported cancers include lung, gastric, and prostate cancer, constituting approximately 50% of all cancers detected at or after the diagnosis of AIP. However, the time span of both AIP and cancer was not defined and might have introduced bias. Available data need to be interpreted with caution as no studies have yet compared the incidence of the most common cancers in AIP patients directly to age-grouped and gender-matched controls in the general population.

To address this lack of knowledge a worldwide, multicenter, retrospective cohort study of AIP patients is initiated founded in the Pancreas2000 framework. With this trial cancer incidence and prevalence will be assessed for AIP patients and compared to age-matched controls.

The trial is based on a REDCap questionnaire containing following information.

  1. Demographic details Month and year of birth Survival status month and year of death, if applicable Gender (Male, Female) Ethnicity (Caucasian, Hispanic, African, Asian, Arabic, Other, Unknown) Weight and height for the purpose of calculating body mass index Tobacco status (Current, Former, Never) incl. "smoking pack-years" if applicable Alcohol consumption (Current daily, current occasionally, Former, Never, Not available) History of other autoimmune diseases (not IgG4-related) (No, Sjögren's' syndrome, Rheumatoid arthritis, Sarcoidosis, Autoimmune thyroiditis (NOT IgG4 related), Other) History of inflammatory bowel disease (Yes, No, Unknown) Family history of cancer (Yes, No, Unknown)
  2. AIP characteristics Month and year of diagnosis AIP The classification system used for original diagnosis (ICDC, HISORT, Asian, Unify) ICDC diagnosis type (Type 1, Type 2, Not otherwise specified (NOS) AIP) ICDC diagnosis level (Definite, Probable) ICDC parameters fulfilled for diagnosis (Histology, Serum IgG4, Imaging, Improvement after steroid treatment, Other organ involvement) Serum IgG4 (1-2 over upper limit, >2 over the upper limit, >4 over the upper limit) Imaging (Focal enlargement, Whole organ enlargement (sausage-like), Other) Other organ involvement (Salivary/lacrymal glands, Retroperitoneum/ kidneys, Bile ducts/liver, Musculoskeletal system, Gastrointestinal tract: Intestines, colon, esophagus, Vasculitis (e.g., aortitis), Enlarged lymph nodes, IBD) Presenting symptoms of AIP (None, Jaundice, Acute pancreatitis, Weight loss, Abdominal pain, New onset of diabetes) Medical treatment for AIP (Prednisone, Rituximab, Azathioprine, 6-mercaptopurine, Methotrexate, Mycophenolate mofetil, other) Interventional treatment for AIP (Partial pancreatectomy, Biliary stent placement, Other) AIP relapse (No relapse, 1-2 relapse(s), 3-4 relapses, >5 relapses, Unknown) AIP-related complications (No, Diabetes mellitus, Pancreatic exocrine insufficiency, Other) Month and year of last contact
  3. Cancer Diagnosis Month and year of diagnosis of cancer Number of cancer diseases (1,2,3,4) Cancer type (list according to the World Health Organization) Cancer-related death (yes, no) In case of more than one cancer, specifically which cancer caused death

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized incidence ratio (SIR) of first invasive cancer
Time Frame: up to 20 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of cancer diagnoses 12 months prior to AIP diagnosis
Time Frame: 12 months prior to AIP diagnosis
We will count if there is a previous cancer diagnosis (yes/no) and from medical records (ICD code according to cancer registry) 12 moths prior to AIP diagnosis and determine prevalence in %
12 months prior to AIP diagnosis
Risk factor associated with cancer diagnosis.
Time Frame: up to 20 years
For every case other possible risk factor for cancer will be assesed such as the gender (female, male), the body mass index (BMI), the type of AIP (type 1, type 2), smoking, diabetes mellitus after diagnosis of AIP , Elevate IgG4 levels at diagnosis, maintainance treatmet, other organ involvement.
up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Goettingen

Collaborators

Aalborg University Hospital
University Hospital Munich
Tartu University Hospital
University Medical Centre Maribor
University Hospital in Halle

Investigators

  • Principal Investigator: 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
  • Study Chair: Ivonne Regel, PhD, University Hospital of Munich (LMU)
  • Study Chair: Jonas Rosendahl, MD, PhD, University Hospital Halle (Saale)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-02558

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be available only to core group, not other researches. Core group retains right to perform post-hoc analyses, these proposals will be reviewed and granted by the steering committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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