Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

Molecular Detection of Advanced Neoplasia in Pancreatic Cysts (IN-CYST)

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreas Cyst
• Intervention / Treatment: Diagnostic test: Blood, stool, pancreatic juice and cyst fluid collection; Procedure: Endoscopy Exam; Procedure: Pancreatic Surgery

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.

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: IN-CYST Team; Phone Number: 2 1-833-250-5364; Email: rstincyststudy@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: IN-CYST Team; Phone Number: 2 1-833-250-5364; Email: rstincyststudy@mayo.edu
      • Principal Investigator: Shounak Majumder, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Surgical; 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.	Diagnostic test: Blood, stool, pancreatic juice and cyst fluid collection; 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.; Procedure: Pancreatic Surgery; Surgical resection of pancreatic cyst
Experimental: Clinical Follow-up; 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	Diagnostic test: Blood, stool, pancreatic juice and cyst fluid collection; 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.; Procedure: Endoscopy Exam; Clinically indicated endoscopic ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biospecimen Acquisition	Number of biospecimens collected	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	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Shounak Majumder, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2018
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 24, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Digestive System Diseases; Pancreatic Diseases; Cysts; Pancreatic Cyst; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Defecation; Blood Specimen Collection
• Other Study ID Numbers: 17-008436; 2U01CA210138 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No