Markers in Acute Pancreatitis-1

NCT05279079 | Completed DMC

• 1 other identifier: UoL001572
• Study Type: observational
• Target: 175
• Locations: 3 countries
• Sites: 4

Brief Summary

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.

Conditions

Acute Pancreatitis Drug-Induced

Outcome Measures

Primary Outcomes (1)

• 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

  Day of admission

Secondary Outcomes (5)

• Pancreatic enzyme biomarker

  Day of admission

• MicroRNA panel

  Days 4 and 14 after admission

• Severity of AP

  Within 90 days of admission

• Patient reported outcome

  Days 4 and 14

• Progress of MAP-1

  Two years

Study Arms (6)

Group 1

Drug-associated AP: patients aged 18 or more years undergoing drug treatment that has a defined risk of AP prior to and at the onset of AP

Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis

Group 2

Other cause AP: patients aged 18 or more years not undergoing drug treatment that has a defined risk of AP prior to and at the onset of AP

Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis

Group 3

Chronic pancreatitis: patients aged 18 or more years with symptomatic chronic pancreatitis confirmed by CT or MRI

Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis

Group 4

Pancreas cancer: patients aged 18 or more years with biopsy proven pancreas cancer

Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis

Group 5

Diabetes mellitus: patients aged 18 or more years with type 1 or type 2 diabetes mellitus in receipt of insulin or oral hypoglycaemics

Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis

Group 6

Healthy volunteers

Diagnostic Test: Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis

Interventions

Assessment of accuracy of microRNA and pancreatic enzyme markers in blood and/or urine in the detection and/or prediction of severity of drug-associated acute pancreatitis DIAGNOSTIC_TEST

Panel of microRNA and pancreatic enzyme biomarkers

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants aged 18 years or more, comprised of 6 Groups: Group 1: Drug-associated AP Group 2: Other cause AP Group 3: Chronic pancreatitis Group 4: Pancreas Cancer Group 5: Diabetes mellitus Grouip 6: Healthy volunteers

You may qualify if:

• Drug-associated AP: patients ≥18 years old undergoing drug treatment that has a defined risk of AP prior to and at the onset of AP and admitted to recruiting hospitals with a diagnosis of AP established by two of: (i) typical continuous upper abdominal pain (in this study for up to 2 days in duration prior to admission); (ii) amylase and/or lipase 3 or more times the upper limit of normal; (iii) characteristic findings on abdominal imaging (if undertaken urgently by computerised tomography scan (CT) or magnetic resonance imaging (MRI); and who undergo their first study blood sampling within 24 hours of admission to hospital.
• Other cause AP: patients ≥18 years old not undergoing drug treatment that has a defined risk of AP and admitted to recruiting hospitals with a diagnosis of AP established by two of: (i) typical continuous upper abdominal pain (in this study for up to 2 days in duration prior to admission); (ii) amylase and/or lipase 3 or more times the upper limit of normal; (iii) characteristic findings on abdominal imaging (if undertaken urgently by CT or MRI) and undergo their first study blood sampling within 24 hours of hospital admission.
• Chronic pancreatitis: patients with symptomatic chronic pancreatitis and diagnostic abnormalities identified by CT and/or MRI and who undergo study blood sampling as an outpatient.
• Pancreatic cancer: patients presenting with biopsy-proven or presumed pancreatic cancer and who undergo study blood sampling as an outpatient; in patients with a presumptive diagnosis of pancreatic cancer, blood and urine samples will be analysed after histological confirmation.
• Diabetes mellitus: adult patients with type 1 or type 2 diabetes mellitus treated with insulin and/or oral anti-hyperglycaemic medication for at least 3 months and ongoing and who undergo study blood sampling as an outpatient.
• Healthy volunteers: normal, healthy individuals aged ≥18 years old without evidence of systemic disease who have required no hospital intervention within the last year and received no drug treatment within the last 3 months and are severe acute respiratory distress syndrome corona virus 2 (SARS-CoV-2) negative.

You may not qualify if:

• Drug-associated AP: onset of continuous abdominal pain more than 2 days prior to admission to hospital; known previous AP within the last 3 months; known chronic pancreatitis; known pancreatic or hepatobiliary malignancy; previous necrosectomy or pancreatic surgery; known prior type 1 or type 2 diabetes mellitus. Patients will not be excluded if they are undergoing drug treatment that has a defined risk of AP prior to and at the onset of AP and an alternative cause for AP is identified (including after recruitment and blood sampling).
• Other cause AP: undergoing drug treatment that has a defined risk of AP (such patients should be considered for recruitment into Group 2); onset of continuous abdominal pain more than 2 days prior to admission to hospital; known previous AP within the last 3 months; known chronic pancreatitis; known pancreatic or hepatobiliary malignancy; previous necrosectomy or pancreatic surgery; type 1 or type 2 diabetes mellitus.
• Chronic pancreatitis: hospital admission with AP within the last three months; known pancreatic or hepatobiliary malignancy; previous necrosectomy or pancreatic surgery; type 1 or type 2 diabetes mellitus.
• Pancreatic cancer: hospital admission with AP within the last 3 months; known chronic pancreatitis; previous necrosectomy or pancreatic surgery and/or chemotherapy prior to sampling; type 1 or type 2 diabetes mellitus.
• Diabetes mellitus: hospital admission with AP within the last 3 months; known type 3c diabetes mellitus; known history of acute or chronic pancreatitis; known history of cystic fibrosis, known history of pancreatic or hepatobiliary malignancy; known history of necrosectomy or pancreatic surgery; gestational diabetes mellitus; monogenic diabetes mellitus syndromes; post-transplantation diabetes mellitus; diabetes mellitus attributed to drugs or toxins.
• Healthy volunteers: abnormal physical examination, abnormal routine haematology, urea, electrolytes and/or liver function tests; evidence of systemic disease; solid or haematological neoplasia within the last 5 years; hospital intervention within last 12 months; scheduled drug treatment within last 3 months and/or as required drug treatment within the last 4 weeks; infection or other sources of acute inflammation within the last 3 months.

Sponsors & Collaborators

• University of Liverpool: lead
• Innovative Medicines Initiative: collaborator
• TransBioLine Consortium: collaborator
• Liverpool University Hospitals NHS Foundation Trust: collaborator
• Klinikum der Universität München: collaborator
• Hospital Regional de Malaga: collaborator

Study Sites (4)

LMU Klinikum München

Munich, Bavaria, 81377, Germany

Location

Hospital Regional Universitario de Málaga

Málaga, Málaga, 29010, Spain

Location

Royal Liverpool University Hospital

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

Aintree University Hospital

Liverpool, Merseyside, L9 7AL, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (10 ml in ethylene diamine tetra-acetic acid, EDTA, 8.5 ml in serum separator tube, SST, 2.5 ml in RNA PAXgene) and urine samples (50 ml collected in Falcon or other tube) will be taken at a single sampling time point from individuals in all groups. These samples will be taken on hospital admission from recruited patients in Groups 1 and 2. Further blood samples (10 ml in EDTA, 8.5 ml in SST and 2.5 ml in RNA PAXgene) will be taken at Day 4 (+/- 1 day) and Day 14 (+/- 2 days) from participants in Groups 1 and 2 from within the United Kingdom.

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Robert Sutton, MD FRCS PhD

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 15, 2022
• Study Start: January 25, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

DE (1); GB (2); ES (1)