NCT03855800

Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreas Cyst

Interventions

Type	Name	Description
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) 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.
PROCEDURE	Pancreatic Surgery	Surgical resection of pancreatic cyst
PROCEDURE	Endoscopy Exam	Clinically indicated endoscopic ultrasound

Timeline

• Start date: 2018-05-11
• Primary completion: 2030-12-30
• Completion: 2030-12-30
• First posted: 2019-02-27
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States