Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT03855800

Conditions

Pancreas Cyst

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Blood, stool, pancreatic juice and cyst fluid collection

Pancreatic Surgery

Endoscopy Exam

Study Details

Brief summary:

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.

Conditions

Pancreas Cyst

Study ID

NCT03855800

Start date

May 11, 2018

Status verified date

May, 2026

Completion date

Dec 30, 2030

Anticipated

Primary completion date

Dec 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

800 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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.

Interventions

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.

Pancreatic Surgery

Surgical resection of pancreatic cyst

Endoscopy Exam

Clinically indicated endoscopic ultrasound

Primary outcome measure

  • Biospecimen Acquisition [ Time Frame: 5 years ]
  • High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

IN-CYST Team

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

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

IN-CYST Team

833-250-5364rstincyststudy@mayo.edu

Principal Investigator:

Shounak Majumder, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-02.