CompletedNot Applicable

Markers in Acute Pancreatitis-1

Germany, Spain, United Kingdom175 participantsStarted 2023-01-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

MicroRNA panel

Timeframe: Day of admission

Trial details

NCT IDNCT05279079

SponsorUniversity of Liverpool

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-31

View on ClinicalTrials.gov More Acute Pancreatitis Drug-Induced trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Markers in Acute Pancreatitis-1

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Markers in Acute Pancreatitis-1

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria