Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

This study is looking for better ways to find out if pancreatic cysts (fluid-filled sacs in the pancreas) have changes that could become cancer. Researchers are testing new methods using samples of your blood, stool, pancreatic juice, and cyst fluid. You might be able to join if you are 18 or older, have certain types of pancreatic cysts (Fukuoka worrisome or high-risk criteria), and have not had pancreatic cancer or surgery before. The study aims to see if these new tests can help diagnose high-grade dysplasia (pre-cancerous cells) or cancer within 5 years. The current status of this study is unclear.

Study design
This interventional study plans to enroll 800 participants. Participants will be assigned to either an Immediate Surgery group or a Clinical Follow-up group based on their doctor's decision.
What's involved
You would provide blood and stool samples at the beginning of the study. If you are in the Immediate Surgery group, you might also have pancreatic juice collected and undergo pancreatic surgery or an endoscopy exam (endoscopic ultrasound).
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes related to biospecimen acquisition and cancer diagnosis for 5 years.

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NCT03855800

Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

Recruiting
NAAges 18+InterventionalDiagnostic
Mayo Clinic
~800 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Blood, stool, pancreatic juice and cyst fluid collectionPancreatic SurgeryEndoscopy Exam

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biospecimen Acquisition
Measured over 5 years
+1 more outcome measured
Pancreas Cyst
1 sites across 1 states
Minnesota1
  • Shounak Majumder, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with pancreatic cystic lesions meeting Fukuoka worrisome or Fukuoka high-risk criteris
Patients with suspected cystic neoplasm of the pancreas
Able to provide written informed consent

Exclusion

Pregnant and/or nursing
Incarceration
Imaging showing possible pancreatic cancer
Prior history of pancreatic cancer or pancreatic surgery
History of receiving systemic chemotherapy or abdominal radiation within the last 5 years
Previous therapy for a pancreatic cystic lesion
History of pancreatic necrosis
Diagnosis of cancer (other than non-melanoma skin cancer) within the last 5 years
  • Biospecimen Acquisition5 years

    Number of biospecimens collected

  • High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group5 years

    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