iMmune SignAtures and Clinical outComes in AP (NCT05878236) | Clinical Trial Compass
RecruitingNot Applicable
iMmune SignAtures and Clinical outComes in AP
United States198 participantsStarted 2023-03-06
Plain-language summary
The MoSAIC study is a prospective, observational study designed to develop an early prediction tool for severe acute pancreatitis (SAP) and define a distinct immunologic profile compared to moderate acute pancreatitis (MAP). The aims are to validate a new multi-cytokine panel for early prediction of SAP and to identify the specific immune cells that correspond with cytokine signatures in early acute pancreatitis to characterize the immune pathways driving the development of SAP. Participants will provide blood samples and complete patient surveys and interviews within 36 hours of hospital presentation, at 48 hours, and hospital day 7 (if admitted). Data on hospital stay, medical history, clinical course, and severity of disease will be collected.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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
. Age 18-75 years at the time of enrollment
. Diagnosis of acute pancreatitis (AP) according to the revised Atlanta criteria (see definition below)
. Participant is approached by the research team within 36 hours of presentation to the hospital
. Participant fully understands and agrees to participate in all aspects of the study, including providing informed consent, completion of interviews and data forms, and collection of biospecimens
Exclusion criteria
. Diagnosis of definite chronic pancreatitis (CP) at enrollment (see also study definitions) based on either of the following criteria met by computed tomography (CT) scan (including non-contrast enhanced) or Magnetic resonance Imaging (MRI) or Magnetic Resonance Cholangiopancreatography (MRCP):
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Potential participants with post-ERCP AP who are expected to be hospitalized for less than 48 hours.
. Pancreatic tumors, including ductal adenocarcinoma, neuroendocrine tumors, and metastasis.
. Confirmed or suspected cystic tumor associated with main pancreatic duct dilation or believed to be the cause of AP (in the site-PI's judgment).
. Prior pancreatic surgery, including, but not limited to distal pancreatectomy, pancreaticoduodenectomy, pancreatic necrosectomy, and Frey procedure.
. Severe systemic illness that in the judgment of the investigative team will confound outcome assessments and immunological outcomes or pose additional risk for harm, including the history of solid organ transplant, acquired immunodeficiency syndrome (AIDS), active treatment for cancer (except non-melanoma skin cancer) within 12 months prior to enrollment, chronic kidney disease with eGFR \<30 or on dialysis prior to AP, and cirrhosis (based on imaging or biopsy), or any other medical condition that in the opinion of the site-PI carries a life expectancy of \<12 months.