Prospective, multi-national, multi-centre observational diagnostic study of novel microRNA and protein biomarkers in peripheral blood and/or urine to detect and predict the severity of drug-associated acute pancreatitis (AP), with comparison of the same biomarkers in patients with acute pancreatitis from other causes, chronic pancreatitis, pancreatic cancer, diabetes mellitus and healthy volunteers.
The MAP-1 study is designed to validate microRNA and/or pancreatic digestive enzyme biomarkers for the detection and severity assessment of drug-associated AP, for application to the assessment of adverse reactions to drugs in development or drugs already developed for other indications. The study will also assess the clinical utility of these biomarkers in AP from other causes, but is not designed to determine whether the biomarkers could be used in place of amylase and/or lipase in the standard clinical diagnosis of AP or to distinguish between the many differential diagnoses of AP. Selection is in progress of the microRNAs and pancreatic digestive enzyme biomarkers to be validated in this study, this selection being made from prospectively biobank samples obtained in a separate observational study that has separate ethical approval. The pre-selected microRNAs and pancreatic digestive enzymes will be measured in the blood and urine of patients on admission to hospital with drug-associated acute pancreatitis (Group 1, 75 participants in receipt of one or more drugs on a defined list of drugs associated with acute pancreatitis) or other cause acute pancreatitis (Group 2, 250 participants not in receipt of any of the defined drugs). The same biomarkers will also be measured in blood and urine samples from contrast groups of patients with chronic pancreatitis (Group 3, 25 participants), pancreas cancer (Group 4, 25 participants), type I or II diabetes mellitus (Group 5, 25 participants) and healthy volunteers (Group 6, 100 participants). All participants will be at least 18 years old. MicroRNAs will be measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) and pancreatic enzymes by mass spectrometry.
Study Type
OBSERVATIONAL
Enrollment
500
Panel of microRNA and pancreatic enzyme biomarkers
LMU Klinikum München
Munich, Bavaria, Germany
Hospital Regional Universitario de Málaga
Málaga, Málaga, Spain
Royal Liverpool University Hospital
Liverpool, Merseyside, United Kingdom
Aintree University Hospital
Liverpool, Merseyside, United Kingdom
MicroRNA panel
Scale of change from normal (healthy volunteer values) of a panel of microRNAs measured in blood and urine samples from patients with mild, moderate or severe drug-associated AP during the first 24 hours of admission, confirming specificity by comparison with results from patients with other pancreatic diseases
Time frame: Day of admission
Pancreatic enzyme biomarker
Scale of change from normal (healthy volunteer values) of a selected pancreatic enzyme biomarker in blood and/or urine taken from patients with mild, moderate or severe drug-associated AP during the first 24 hours of admission, confirming specificity by comparison with results from patients with other pancreatic diseases
Time frame: Day of admission
MicroRNA panel
Scale of change of circulating microRNAs measured in blood samples on Day 4 (+/- 1 day) and Day 14 (+/- 2 days) after admission to assess progression of AP
Time frame: Days 4 and 14 after admission
Severity of AP
Determination of AP severity will be made according to the Revised Atlanta Classification
Time frame: Within 90 days of admission
Patient reported outcome
Application of the PAtieNt-rePoRted OutcoMe scale in acute pancreatItis - an international proSpEctive cohort study (PAN-PROMISE) scale
Time frame: Days 4 and 14
Progress of MAP-1
Progress of recruitment of patients into MAP-1
Time frame: Two years
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