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RecruitingInterventional

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

NCT ID: NCT03855800Sponsor: Mayo ClinicLast updated: 2026-06-02

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.

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.

Arms & interventions

  • Diagnostic TestBlood, 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.

  • ProcedurePancreatic Surgery

    Surgical resection of pancreatic cyst

  • ProcedureEndoscopy Exam

    Clinically indicated endoscopic ultrasound

Outcome measures

Primary

  • 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

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

    Time frame: 5 years

Eligibility criteria

Sex: AllAge: 18 Years to 120 YearsHealthy volunteers: No
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 locations (1)

Mayo Clinic

Rochester, Minnesota, 55905

Recruiting
IN-CYST Team · Contact
833-250-5364rstincyststudy@mayo.edu
Shounak Majumder, MD · Principal Investigator
Molecular Detection of Advanced Neoplasia in Pancreatic Cysts | Cancerify