Molecular Detection of Advanced Neoplasia in Pancreatic Cysts
Pancreas Cyst
About this trial
This is an interventional diagnostic trial for Pancreas Cyst
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Mayo ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Clinical Follow-up
Surgical
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 3 years, and interval medical records will be obtained and reviewed. During follow-up results of clinically indicated follow-up imaging studies will be abstracted
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.