NCT03855800NARecruiting
Molecular Detection of Advanced Neoplasia in Pancreatic Cysts
Mayo Clinic
Start Date
5/11/2018
Completion Date
12/30/2030
Summary
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.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to 120 years
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
Interventions
DIAGNOSTIC_TEST
Blood, stool, pancreatic juice and cyst fluid collection
PROCEDURE
Pancreatic Surgery
PROCEDURE
Endoscopy Exam
Conditions
Pancreas Cyst
Locations
Mayo Clinic
Rochester, Minnesota 55905
United States