An interventional study of Blood, stool, pancreatic juice and cyst fluid collection and Pancreatic Surgery in Pancreas Cyst, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic
Researchers are trying to find out whether new tests ("biomarkers") of blood, stool, pancreas cyst fluid, or pancreas juice can be used to diagnose malignant or pre-malignant changes in pancreas cysts.
Subjects with Fukuoka Worrisome (FW) or Fukuoka High Risk (FHR) pancreatic cysts will be enrolled and assigned to Immediate Surgery or Clinical Follow-up groups based on clinical management as determined by the treating physicians. Blood, stool, pancreas cyst fluid, and pancreas juice specimens will be collected from participants.
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This study's planned enrollment of 800 is above the median of 67 across 40 interventional studies indexed under Pancreatic Cyst.
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Exclusion Criteria:
Participants not undergoing surgery will be assigned to the "Clinical Follow-up" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. All participants in the Clinical Follow-up group will be contacted yearly for a telephone interview until they undergo surgery, die, receive a diagnosis that excludes them from the study, or for 5 years, and interval medical records will be obtained and reviewed. During follow-up results of clinically indicated follow-up imaging studies will be abstracted
Diagnostic Test: Blood, stool, pancreatic juice and cyst fluid collection · Procedure: Endoscopy Exam
Participants scheduled for surgical resection after their initial clinical evaluation will be assigned to the "Immediate Surgery" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. Participants in the Immediate Surgery group will be followed until the surgical pathology of their pancreatic cyst is known.
Diagnostic Test: Blood, stool, pancreatic juice and cyst fluid collection · Procedure: Pancreatic Surgery
Blood and stool will be collected at baseline from all study participants. Those in the Immediate Surgery group may undergo endoscopic pancreatic juice collection before surgery, either at the time of a clinically indicated endoscopic ultrasound (EUS) exam or during an optional pre-operative research endoscopy. Pancreatic cyst fluid will also be obtained from all participants in the Immediate Surgery group, either at the time of surgery, or during a clinically indicated preoperative EUS FNA procedure, or both. Pancreatic juice and cyst fluid will be collected opportunistically from participants in the Clinical Follow-up group who undergo a clinically indicated EUS, EUS FNA, or endoscopy exam.
Surgical resection of pancreatic cyst
Clinically indicated endoscopic ultrasound
Biospecimen Acquisition
Number of biospecimens collected
Time frame: 5 years
High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group
To validate the diagnostic accuracy of cyst fluid methylated DNA marker (MDM) assays for detection of HGD and cancer in pancreatic cysts undergoing surgical resection
Time frame: 5 years
High grade dysplasia (HGD) or cancer diagnosis in clinical follow up group
To evaluate the performance of cyst fluid MDM assays for predicting development of HGD or cancer during 3-year follow-up in study patients who are initially managed non-operatively
Time frame: 5 years
Plan to share: No
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