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Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

Not Applicable
Recruiting
Conditions
Pancreas Cyst
Interventions
Diagnostic Test: Blood, stool, pancreatic juice and cyst fluid collection
Procedure: Pancreatic Surgery
Procedure: Endoscopy Exam
Registration Number
NCT03855800
Lead Sponsor
Mayo Clinic
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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
800
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Clinical Follow-upBlood, stool, pancreatic juice and cyst fluid collectionParticipants 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
SurgicalBlood, stool, pancreatic juice and cyst fluid collectionParticipants 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.
SurgicalPancreatic SurgeryParticipants 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.
Clinical Follow-upEndoscopy ExamParticipants 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
Primary Outcome Measures
NameTimeMethod
Biospecimen Acquisition5 years

Number of biospecimens collected

High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group5 years

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

Secondary Outcome Measures
NameTimeMethod
High grade dysplasia (HGD) or cancer diagnosis in clinical follow up group5 years

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

Trial Locations

Locations (1)

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

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