Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

Mayo Clinic

Status: Enrolling

Conditions: Pancreas Cyst

Treatments: Procedure: Endoscopy Exam; Diagnostic Test: Blood, stool, pancreatic juice and cyst fluid collection; Procedure: Pancreatic Surgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03855800

17-008436

2U01CA210138 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Clinical Follow-up

Experimental group

Description:

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

Treatment:

Diagnostic Test: Blood, stool, pancreatic juice and cyst fluid collection

Procedure: Endoscopy Exam

Surgical

Other group

Description:

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.

Treatment:

Procedure: Pancreatic Surgery

Diagnostic Test: Blood, stool, pancreatic juice and cyst fluid collection