Molecular Detection Of Advanced Neoplasia In Pancreatic Cysts

Study Overview

Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

Researchers are trying to find out whether new tests (ȫiomarkers") 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.

Pancreas Cyst

DIAGNOSTIC_TEST: Blood, stool, pancreatic juice and cyst fluid collection
PROCEDURE: Pancreatic Surgery
PROCEDURE: Endoscopy Exam

17-008436
2U01CA210138 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-01-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-19
First Submitted that Met QC Criteria 2019-02-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-08-26
First Posted (ESTIMATED) 2019-02-27	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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	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) exa PROCEDURE: Endoscopy Exam Clinically indicated endoscopic ultrasound
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 Immed	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) exa PROCEDURE: Pancreatic Surgery Surgical resection of pancreatic cyst

Participant Group/Arm

Intervention/Treatment

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

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) exa

PROCEDURE: Endoscopy Exam

Clinically indicated endoscopic ultrasound

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 Immed

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) exa

PROCEDURE: Pancreatic Surgery

Surgical resection of pancreatic cyst

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: IN-CYST Team

Phone Number: 1-833-250-5364

Email: rstincyststudy@mayo.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Shounak Majumder, MD, Mayo Clinic

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record