Molecular Detection of Advanced Neoplasia in Pancreatic Cysts
NCT03855800 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800
Last updated 2025-12-17
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
Interventions
- 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
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Shounak Majumder, MD · Mayo Clinic
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-11
- Primary Completion
- 2030-12-30
- Completion
- 2030-12-30
Countries
- United States
Study Locations
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