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.

Study Timeline

• Study Start: 2018-05-11
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-02-24
• Study First Posted: 2019-02-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21
• Primary Completion: 2030-12-30
• Study Completion: 2030-12-30

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

Group	Intervention	Description
Clinical Follow-up	Blood, stool, pancreatic juice and cyst fluid collection	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
Surgical	Blood, stool, pancreatic juice and cyst fluid collection	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.
Surgical	Pancreatic Surgery	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.
Clinical Follow-up	Endoscopy Exam	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

Primary Outcome Measures

Name	Time	Method
Biospecimen Acquisition	5 years	Number of biospecimens collected
High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group	5 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

Name	Time	Method
High grade dysplasia (HGD) or cancer diagnosis in clinical follow up group	5 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