Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06328101
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-02-15
Brief Title:
Autoimmune Pancreatitis Pancreatic and Extrapancreatic cAnceR AiPPEAR
Sponsor:
University Medical Center Goettingen
Organization:
University Medical Center Goettingen
Study Overview
Official Title:
A Multicenter Retrospective Study on Autoimmune Pancreatitis Pancreatic and Extrapancreatic cAnceR AiPPEAR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AiPPEAR
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
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 its 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 Sjögrens 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 Salivarylacrymal glands Retroperitoneum kidneys Bile ductsliver Musculoskeletal system Gastrointestinal tract Intestines colon esophagus Vasculitis eg 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 relapses 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 1234 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
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 Sjögrens 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 Salivarylacrymal glands Retroperitoneum kidneys Bile ductsliver Musculoskeletal system Gastrointestinal tract Intestines colon esophagus Vasculitis eg 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 relapses 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 1234 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None