Autoimmune Pancreatitis Type 1AiPPEARNCT06328101
Autoimmune Pancreatitis, Pancreatic and Extrapancreatic cAnceR (AiPPEAR)
An observational study of Autoimmune Pancreatitis Type 1 and Autoimmune Pancreatitis Type 2, run by University Medical Center Goettingen.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Pancreatitis Type 1, Autoimmune Pancreatitis Type 2
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with AIP after 2005, including type 1, type 2, and not-otherwise-specified (NOS) AIP, regardless of the diagnostic criteria used.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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?
Read the 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.
- 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)
- 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
- 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
- Keywords
- autoimmune pancreatitis, cancer, risk, pancreatic cancer, hepatobiliary cancer
- Medical subject headings
- Autoimmune Pancreatitis, Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 20 years
Secondary outcomes (2)
The prevalence of cancer diagnoses 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 %
Measured: 12 months prior to AIP diagnosis
Risk factor associated with cancer diagnosis.
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.
Measured: up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Autoimmune Pancreatitis Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Centre Maribor, Aalborg University Hospital, University Hospital Munich, Tartu University Hospital, University Hospital in Halle
- Responsible party
- Principal investigator, Christoph Ammer-Herrmenau, University Medical Center Goettingen
- Investigators
- Cecilie Siggaard Knoph, MD, Principal investigator, Univesity Hospital AlborgJulian Cardinal von Widdern, MD, Principal investigator, University Hospital Halle (Saale)Karri Kasse, MD, Principal investigator, Tartu University HospitalIvonne Regel, PhD, Study chair, University Hospital of Munich (LMU)Jonas Rosendahl, MD, PhD, Study chair, University Hospital Halle (Saale)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328101
- Sponsor's protocol ID
- 2023-02558
- Other IDs
- 2023
- Acronym
- AiPPEAR
- Status last verified
- Mar 2024
- First submitted
- 15 Feb 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32552502Shimosegawa 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.
PubMed 21412117Nikolic 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.
PubMed 35526270Lee 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.
PubMed 29362937Lanzillotta 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.
PubMed 35367110Nikolic 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.
PubMed 35807009Lowenfels 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.
PubMed 8479461Kurita 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.
PubMed 38124014Shiokawa 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.
PubMed 23318486Schneider 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.
PubMed 28226313Cardinal 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.
PubMed 39956600
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Retrospective Study on Autoimmune Pancreatitis, Pancreatic and Extrapancreatic cAnceR (AiPPEAR)
- ClinicalTrials.gov ID
- NCT06328101
- Acronym / sponsor ID
- AiPPEAR / 2023-02558
- Keywords
- autoimmune pancreatitis, cancer, risk, pancreatic cancer, hepatobiliary cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Collaborators
- University Medical Centre Maribor, Aalborg University Hospital, University Hospital Munich, Tartu University Hospital, University Hospital in Halle
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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.
- 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)
- 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
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients diagnosed with AIP after 2005, including type 1, type 2, and not-otherwise-specified (NOS) AIP, regardless of the diagnostic criteria used.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
The prevalence of cancer diagnoses 12 months prior to AIP diagnosis
Time frame: 12 months prior to AIP diagnosis
Risk factor associated with cancer diagnosis.
Time frame: up to 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Background: PubMed 32552502Lohr 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.
- Background: PubMed 21412117Shimosegawa 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.
- Background: PubMed 35526270Nikolic 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.
- Background: PubMed 29362937Lee 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.
- Background: PubMed 35367110Lanzillotta 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.
- Background: PubMed 35807009Nikolic 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.
- Background: PubMed 8479461Lowenfels 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.
- Background: PubMed 38124014Kurita 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.
- Background: PubMed 23318486Shiokawa 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.
- Background: PubMed 28226313Schneider 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.
- Derived from this study: PubMed 39956600Cardinal 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilie Siggaard Knoph, MD principal investigator
Univesity Hospital Alborg
Julian Cardinal von Widdern, MD principal investigator
University Hospital Halle (Saale)
Karri Kasse, MD principal investigator
Tartu University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Pancreatitis Type 1 and Autoimmune Pancreatitis Type 2, run by University Medical Center Goettingen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Nikolić, MD (+38651261676, s.nikolic91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized incidence ratio (SIR) of first invasive cancer (time frame: up to 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06328101, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.