Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

Mayo Clinic800 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

800

Conditions

Pancreas Cyst

Interventions

Blood, stool, pancreatic juice and cyst fluid collectionDIAGNOSTIC_TEST

Blood and stool will be collected at baseline from all study participants. Those in the Immediate Surgery group may undergo endoscopic pancreatic juice collection before surgery, either at the time of a clinically indicated endoscopic ultrasound (EUS) exam or during an optional pre-operative research endoscopy. Pancreatic cyst fluid will also be obtained from all participants in the Immediate Surgery group, either at the time of surgery, or during a clinically indicated preoperative EUS FNA procedure, or both. Pancreatic juice and cyst fluid will be collected opportunistically from participants in the Clinical Follow-up group who undergo a clinically indicated EUS, EUS FNA, or endoscopy exam.

Pancreatic SurgeryPROCEDURE

Surgical resection of pancreatic cyst

Endoscopy Exam

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

Biospecimen Acquisition

Number of biospecimens collected

Time frame: 5 years

High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group

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

Time frame: 5 years

Secondary Outcomes

High grade dysplasia (HGD) or cancer diagnosis in clinical follow up group

To evaluate the performance of cyst fluid MDM assays for predicting development of HGD or cancer during 3-year follow-up in study patients who are initially managed non-operatively

Time frame: 5 years

Central Contacts

IN-CYST Team

CONTACT

1-833-250-5364 rstincyststudy@mayo.edu

Data from ClinicalTrials.gov

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