A Study to Evaluate if New Tests (“biomarkers”) of Blood, Stool, Pancreas Cyst Fluid, or Pancreas Juice can be Used to Diagnose Malignant or Pre-malignant Changes in People with Pancreas Cysts

Overview

About this study

The goal of this protocol is to collect biospecimens in order to prospectively evaluate diagnostic and prognostic performance of MDMs for detection of advanced neoplasia in pancreatic cysts. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients with pancreatic cystic lesions meeting Fukuoka worrisome (FW) or Fukuoka high-risk (FHR) criteria.
  • Patients with suspected cystic neoplasm of the pancreas.
  • Age ≥ 18 years old.
  • Able to provide written informed consent.

Exclusion Criteria:

  • Pregnant and/or nursing.
  • Incarcerated.
  • Imaging features indicative of pancreatic cancer such as presence of a solid pancreatic mass, encasement of peri-pancreatic vessels, malignant intra-abdominal lymphadenopathy, or hepatic and/or other distant metastasis.
  • 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 (such as ethanol injection or cyst drainage).
  • Medical co-morbidities that increase the risk of endoscopy (ASA class ≥ 3); however, the patient can be enrolled despite this criterion if endoscopy will be conducted for clinical indications (not for research alone).
  • History of pancreatic necrosis.
  • Diagnosis of cancer (other than non-melanoma skin cancer) within the last 5 years.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shounak Majumder, M.D.

Open for enrollment

Contact information:

IN-CYST Team

(800) 914-7962

More information

Publications

Publications are currently not available
.
CLS-20425954

Mayo Clinic Footer